Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Pediatric Oncology

Hospitals offering this trial


2001-283
COG ANBL00B1: NEUROBLASTOMA BIOLOGY STUDIES

This study is for patients who have neuroblastoma, a tumor of nerve cells usually found in the stomach, chest, or neck of young children. In order to confirm the diagnosis, it may be necessary to get a sample of the tumor by surgery. This will either be a biopsy (removal of a small amount of tumor) or a resection (removal of most of or all of the tumor). Sometimes the diagnosis can be made with a bone marrow aspirate and biopsy (sample of the material inside a bone). Sometimes doctors need to do tests on the tumor tissue to help confirm the diagnosis as well as to help find the best method of treatment.

We would like to collect samples of tumor, blood and/or bone marrow to learn more about neuroblastoma. We would like to use some of the tumor tissue that is not needed for diagnosis for some specialized laboratory tests. These studies will determine the amount of DNA (genetic material) in the tumor cells, as well as whether multiple copies of gene called "MYCN" are present in the tumor cells. The results of these tests may be used to dertermine the best therapy for patients on this study.

Other tests will be done for research purposes only and will not affect care of patients. These tests are an optional part of this study. They will examine whether genes called "supressor genes" are inactivated (turned off or stopped). Specifically, analysis of chromosomes 1, 11, 14, and 17 will be performed. In addition, the level of expression (how much is made) of genes involved in normal nerve and cancer growth will be examined.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2001-284
CCG D9902: A COG SOFT TISSUE SARCOMA DIAGNOSIS, BIOLOGY AND BANKING PROTOCOL

This study is for patients who may have a rhabdomyosarcoma (RMS) or non-rhabdomyosarcoma (NRSTS). This study has three main goals.

The first goal is to find out the exact type of soft tissue sarcoma that subjects have so that each subject is given the treatment with the best chance of curing their disease. This is done by having experts in the diagnosis of soft tissue sarcomas look at the tumor cells and do some tests with the tumor tissue.

The second goal is to collect soft tissue specimens to learn more about RMS and NRSTS, and the blood, serum, and bone marrow of people with these tumors. This biology research may include such things as DNA studies to identify changes in the genetic information in the tumors that is causing the tumor and might explain why some drugs work or do not work. We know that new tests will be developed over time and that these will add to our knowledge of these tumors. As we learn more about these tumors, the study doctors may find features that are "predictors" of how treatment drugs might work against some tumors.

The third goal is to collect specimens for the COG soft tissue sarcoma tissue bank for future research.

Lombardi/MedStar Georgetown Hospital

Forms:


2004-050
COG ABTR01B1: A CHILDREN'S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING PEDIATRIC RESEARCH SPECIMENS INCLUDING RARE PEDIATRIC TUMORS.

Medical scientists want to find better ways to detect tumors early and to find ways to prevent the occurrence of tumors. To do this, they need more information about the characteristics of childhood tumors. Therefore, they want to study samples of tumor tissues and molecules in the blood that may be related to tumors, especially malignant tumors. Some researchers look at diseases that are passed on in families. They may look at the tissue for genetic causes and signs of disease. When cancer is suspected, a sample of tumor is removed for evaluation. Any tissue that has already been removed but is not needed to make the diagnosis is usually discarded. This tissue can be used for special research studies. Drawing samples of blood and obtaining samples of bone marrow are often a part of the routine evaluation of patients suspected of having cancer. When blood is drawn for routine tests, patients will be asked to give an extra three teaspoonfuls of blood for special research studies. Likewise, when a bone marrow sample is being obtained for clinical purposes, patients are asked to provide an extra 1-2 teaspoons of bone marrow. Characteristics in the samples of blood may be compared with those in the tumor.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2006-040
COG ANHL04B1: RARE AND CUTANEOUS NON-HODGKIN LYMPHOMA REGISTRY.

This study is to determine the clinical features, treatment, and outcome of rare pediatric NHL; to determine the pathologi and biologic features of rare pediatric NHL including molecular diagnostics and flow cytometry; to establish a bank of pathologically reviewed rare NHL and make specimens of blood and tissue available to qualified researchers; and to determine sub-groups of rare NHL that could be targeted for future biologic, pathologic, or therapeutic studies.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2006-181
COG AREN03B2: RENAL TUMORS CLASSIFICATION, BIOLOGY AND BANKING STUDY.

This study will classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight and loss of heterozygosity for chromosomes 1p and 16q, to thereby define eligibility for a series of therapeutic studies and to maintain a biological sample bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2007-239
COG AALL05B1: A Childrens Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens.

The purpose of this study is to collect leukemia cells and normal blood cells from patients with ALL that relapse, and to store them for use in future research studies. This storage is sometimes called "CellBanking. Specimens collected as part of this study will only be used for research and no results from any studies performed will be given to you or your doctor or put in your health records.

Lombardi/MedStar Georgetown Hospital

Forms:

Main
Assent (7-12)
Assent (13-17)
Bone sample

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2007-445
COG AREN0532: TREATMENT FOR VERY LOW, LOW AND STANDARD RISK FAVORABLE HISTOLOGY WILMS TUMOR.

You are being asked to take part in this study because you have a favorable histology Wilms tumor that has some risk of returning after treatment. We know because your tumor cells and the images of your tumor and its location in the body were looked at and studied as a result of your enrollment in AREN03B2. Study doctors also did some tests to find out the genetic make-up of your tumor. They were looking especially for a genetic change called loss of heterozygosity (LOH). Your study doctor can tell you these details about your tumor and its stage (staging means knowing where the tumor started and whether it has spread to other areas of the body)

Lombardi/MedStar Georgetown Hospital

Forms:

Chemotherapy Arm
Surgery Only and Observation
Relapse following Observation
Assent (7-12)
Assent (13-17)

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2008-294
ACCRN07-Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN).

First, you are being asked to provide permission to have the following information sent from your hospital to the Childhood Cancer Research Network: " your name " your birth date " your postal/zip code " type and characteristics of your cancer " date the cancer was diagnosed " COG institution where you are being treated " social security number " whether you are male or female " your race and your ethnicity Also, the diagnostic laboratory report that provides specific information about your tumor will also be provided to the CCRN if you agree to participate. This additional information is requested to study relationships between geographic location and risk of types of cancer. Second, you are being asked if you are willing to be contacted in the future to consider participating in CCRN research studies that may involve you. This would include allowing your name, home address and telephone number to be entered in the CCRN. You will only be contacted by researchers whose research studies have undergone scientific review and were found to be important. These researchers and their studies will be approved by the Childhood Cancer Research Network. Please read the information sheet called " More about the Childhood Cancer Research Network " for additional information. You are not agreeing to be in any studies right now, just to being asked if you would like to hear about more studies in the future, and it is possible that you will never be contacted.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2008-325
COG AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomized of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)

You are being asked to allow your child to take part in this study because your infant has been diagnosed with acute lymphoblastic leukemia (ALL). Leukemia is cancer of blood cells. It develops in the bone marrow, which is the soft tissue in the center of bones where blood cells are made. ALL is a cancer in which young abnormal infection-fighting white blood cells, called lymphoblasts or blasts, crowd out normal bone marrow cells and spread into the blood stream. Blasts can also spread to the brain, spinal cord, testicles, and other organs.

Infants with ALL can be classified into 1 of 3 risk groups. The term risk refers to the chance of the cancer coming back during or after treatment. The assignment of risk is based on the infants age at diagnosis and the genetics of the leukemia cells. The genetics of infant ALL can be classified as either MLL-G or MLL-R. The leukemia cell genetic test is currently being run on your infants bone marrow. You already signed a consent form for the ALL Classification Study AALL03B1. For that reason, your childs doctor will find out the genetics of your infants ALL in about 10 days.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2008-399
COG AEWS07B1:A COG Study for Collecting and Banking Ewing Sarcoma Specimens

The goal of this study is to collect Ewing Sarcoma tumor specimens and blood and bone marrow samples from patients with these tumors. These specimens will be used by researchers to increase our knowledge about how to diagnose and treat Ewing Sarcoma.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2008-400
COG AOST06B1: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

The goal of this study is to collect osteosarcoma tumor specimens and blood samples from patients with these tumors. These specimens will be used by researchers to increase our knowledge about how to diagnosed and treat osteosarcoma.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2009-098
COG ALTE05N1: Umbrella Long-Term Follow-up Protocol

A Long-Term Follow-Up Center (LTFC) has been created to perform long-term follow up with COG patients. The LFTC is located in the Keck School of Medicines Department of Preventive Medicine at the University of Southern California (USC). Researchers hope that collecting information from as many patients as possible on how they are doing after treatment will help in finding ways to reduce problems related to cancer treatment and improve quality of life.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2009-312
COG AALL07P1: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) 

This study is a Phase 2 study. A Phase 2 study is done to measure the response of a disease to an experimental drug. This study is being done to find out if adding bortezomib to the standard Re-Induction therapy is a helpful and effective therapy for treating children and young adults with relapsed ALL.

The goals of this study are: To measure how effective the combination of bortezomib with standard chemotherapy drugs is at treating children and young adults with relapsed ALL; To find out what effects (good and/or bad) bortezomib, given with standard chemotherapy drugs, has on children and young adults with relapsed ALL.

In addition to the treatment goals, we would like to answer some biology research questions that might benefit future patients. You can choose to be in this clinical trial without taking part in the biology portion of the study. Because we dont know how to use the results of these biology research tests for treatment, they will not be shared with you or your doctor and your treatment will not be changed based on results of any biology research tests that are performed.

We would also like to treat some patients with relapsed lymphoblastic lymphoma (LL) with this same treatment so that we can see if they respond to this therapy in a similar manner to ALL patients. Patients with relapsed LL will not be asked to participate in the biology studies.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2009-373
COG ALTE07C1: Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer: A Groupwide Non-therapeutic Study.

The overall goal of this study is to learn about the neuropsychological (for example, thinking, learning, and remembering) and behavioral functioning of children being treated for cancer. Another goal of this study is to find out if a standard set (called a battery) of neuropsychological and behavioral tests can be consistently completed at all the COG hospitals and at 3 standard time points.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2009-376
COG AAML08B1: Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome 

The condition of TMD in children with Down syndrome is not well understood. More information about TMD would help doctors to determine the best treatment for TMD in the future. The purpose of this study is to collect blood samples from TMD patients for medical research. Research doctors would like to learn more about the biology and characteristics of the disease. They will use samples collected in this study to understand why some of the cases of TMD develop into leukemia and why some dont. They also want to understand what makes the TMD cells different from normal body cells and the types of liver changes that occur. Studies of the biology of TMD will help us learn more about TMD so that we can work towards finding a cure for this disease in the future. The overall goal is to study the biology of TMD to increase our understanding of the disease.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2009-449
COG AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study.

The overall goal of this study is to find ways to get rid of the tumor cells while saving the largest amount of normal kidney tissue possible.

Since this is a rare disease, the research questions can be answered more quickly if many hospitals join together in the research.

The goals of this study are:
- For subjects with bilateral Wilms tumor:
--- To find out if giving three drugs instead of two will help get rid of the tumor cells while saving the largest amount of normal kidney tissue. This is an experimental treatment.
--- To improve survival for patients with Wilms tumor.
- For subjects who have very aggressive tumor cells (called anaplastic or rhabdoid tumors): o To see if having surgery early in the treatment will lead to early identification of aggressive cells and thereby lead to beginning a five-drug chemotherapy drug regimen earlier than standard treatment, that will improve patient survival and spare as much of the normal kidney tissue as possible. This is an experimental treatment.
- For all subjects, to find out if the chemotherapy drugs that will be given after surgery should be based on how the tumor cells have changed (by looking at them under a microscope) after receiving 2 cycles of chemotherapy before the surgery.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2010-005
COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma: A Groupwide Phase III Study

The overall goal of this study is to get rid of the cancer and not have it come back in more children with hepatoblastoma and to decrease the side effects of chemotherapy.

In this study, the risk level for the disease coming back after treatment is either very low, low, intermediate, or high. Subjects are treated according to the risk group they are in.

Other questions that researchers want to answer in this study are:
- Can a rating system called Pretreatment Extent of Disease (or PRETEXT) be used to decide if a tumor can be removed by surgery? Also, do different doctors give the same or different PRETEXT ratings when looking at the same patients tumor on a scan?
- Are there other factors that are present in children with hepatoblastoma that can be used to develop better treatments?
- For low-risk hepatoblastoma patients: Is it possible to give only 2 cycles of C5V (instead of the standard 4 cycles) in addition to taking out the tumor with surgery and still have good treatment success rates?
- For intermediate-risk hepatoblastoma patients: Can doxorubicin (chemotherapy) be given with C5V without causing too many side effects?
- For intermediate-risk and high-risk hepatoblastoma patients: Is it possible for patients to be referred by their doctor to a center with experts in liver transplant surgery by the end of 2 cycles of chemotherapy? And is it then possible for these patients to have their liver transplant done at the end of 4 cycles of chemotherapy?
- For high-risk hepatoblastoma patients: Are vincristine and irinotecan (types of chemotherapy and known as VI) useful chemotherapy drugs for treating patients with high-risk hepatoblastoma?

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2010-144
COG ARST08P1: A Pilot Study to Evaluate Novel Agent Cixutumab (IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC # 742460) in Combination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma

In summary, the experimental chemotherapy on this study is different from the standard chemotherapy in that:
- The drug IMC-A12 is added to high intensity chemotherapy.

The overall goals of this study are:
- To find out the effects, good and/or bad, of giving IMC-A12 in combination with high intensity chemotherapy to subjects with high risk rhabdomyosarcoma or ectomesenchymoma.
- To see if early exposure to a combination of IMC-A12 and high intensity chemotherapy will get rid of the cancer for as long as possible for high risk rhabdomyosarcoma subjects.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2010-318
COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Epedymoma Ages 1 to 21 Years: A Groupwide Phase III Study.

Previous experience has shown that the outlook for subjects with newly diagnosed ependymoma that is treated with standard therapy, described above, is good. A recent single institution study showed that about 3 of every 4 patients whose tumors were completely removed by surgery were disease-free 7 years after treatment, compared to only 1 of 3 patients with tumors that could not be completely removed by surgery. In previous studies, only about 42% to 62% of ependymoma tumors could be completely removed by surgery, however, a more recent national study showed that about 80% of ependymoma tumors could be completely removed by surgery. Tumors that are located in the lower part of the brain or near nerves in the brain are more difficult to take out completely. There are recent studies of young children which have shown that chemotherapy (anti-cancer drug therapy) can help shrink or get rid of ependymoma tumors.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2010-469
COG AALL08B1: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

The purposes of this study are to find out the specific subtype of the leukemia you have. This is needed to decide the type and intensity of therapy that will best treat your disease, to learn more about what causes leukemia and about how to improve treatment in the future. When we say subtype of leukemia, we are talking about the different types of leukemia that help us to assign the disease into separate groups.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2010-470
COG AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL): A Goupwide Phase III Study

The purpose of Part I of this study is to collect information about the leukemia and the effects of treatment. This will be given over 4 weeks. You already signed a consent form for the ALL Classification Study AALL08B1. For that reason, your doctor will know the risk group of the ALL by the end of Induction. We would like to begin treatment with chemotherapy (anti-cancer drugs) as soon as possible. The chemotherapy given during Induction is the current recommended treatment for Standard Risk (SR) ALL.

The overall goal of Part I of this study is to collect information about your leukemia and about the effects of the first phase of treatment, called Induction. You will be offered the chance to take part in other parts of this study once the ALL risk gtoup is known.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-015
COG ACNS0822:Randomized Phase II/III Study of Vorinostat IND 71976 and Local Irradiation OR Temozolomide and Local Irradiation or Bevacizumab IND 7921 and Local Irradiation Followed by Maintenance

The study is being done in 3 parts. Part 1 of this study is to find the dose of vorinostat that can be given safely to children during radiation therapy. Once this dose is known, the study will continue to Part 2. Part 2 of the study will test and compare 3 treatments. Part 3 of this study will compare the 2 best treatments from Part 2. People who are in Part 1 of this study will not be in Part 2 or 3. We are now doing Part 1 of the study. You are being asked to enroll on Part 1 of this study.

The goals of Part 1 of this study are to:
- Find out the dose of vorinostat that can be given safely to children while they are receiving radiation therapy. The combination of vorinostat with radiation therapy is experimental.
The goals of Part 2 of this study are to:
- Find out what effects, good and/or bad, chemoradiotherapy with vorinostat followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of vorinostat with radation therapy is experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
- Find out what effects, good and/or bad, chemoradiotherapy with bevacizumab followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of bevacizumab and temozolomide is experimental.
- Find out what effects, good and/or bad, chemoradiotherapy with temozolomide followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of temozolomide with radiation therapy is not experimental. Miantenance therapy with bevacizumab and temozolomide is experimental.
Compare the effects of the three treatments above to find out which is better at getting rid of or shrinking tumors and has the least amount of side effects.
The goals of part 3 of this study are to:
- Compare the effects of two treatments to find out which is better at getting rid of or shrinking tumors and has the least amount of side effects. The two treatments are:
--- Chemotheradiotherapy with either bevacizumab or vorinostat followed by maintenance therapy with bevacizumab or temozolomide has on people with newly diagnosed high-grade gliomas. The combination of bevacizumab or vorinostat with radiation therapy is experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
--- Chemoradiotherapy with temozolomide followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of temozolomide with radiation therapy is not experimental. Maintenance therapy with bevaicizumab and temozolomide in experimental.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-206
COG ACNS0821: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial: A Groupwide Phase II Study

The overall goals of this study are to: Find out what effects, good and/or bad, giving tomozolomide together with irinotecan daily for 5 days every 28 days has on people with recurrent or refractory medulloblastoma/PNET. Find out what effects, good and/or bad, adding bevacizumab to treatment with temozolomide and irinotecan has on people with recurrent or refractory medulloblastoma/PNET.

 

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Anjum Zaki
Email: aaz2@georgetown.edu
Phone: 202-687-1351

2011-211
COG AEWS1031: A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma: A Groupwide Phase III Study

To find out if adding the drug combination VTC to the standard five-drug chemotherapy for Ewing sarcoma will get rid of the cancer better than the standard five-drug chemotherapy by itself.

In addition to the treatment goals, the study doctors would also like to find out whether an imaging test called a PET scan, which your doctor may want you to have in order to see where the cancer might be could also be useful in finding out if the Ewing sarcoma calls are killed by the treatment.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Anjum Zaki
Email: aaz2@georgetown.edu
Phone: 202-687-1351

2011-276
COG ADVL0921: A Phase II Study of MLN8237 (IND# 102984), a Selective Aurora Kinase Inhibitor, in Pediatric Patients with Relapsed/Refractory Solid Tumors and Leukemias

This is a Phase II study of a drug called MLN8237. In a Phase II study the goal is to find out what effects, good and/or bad, a drug has on people with a type of cancer.

MLN8237 is a drug that in laboratory studies can block or inhibit a protein called aurora A kinase. Aurora A kinase is a naturally occurring protein found in the cells of your body when they divide and multiple. Aurora A kinase may also partly control the ability of certain cancers to grow. MLN8237 is considered experimental because the Food and Drug Administration (FDA) has not approved it for commercial use. We do not know if MLN8327 will work in children. MLN8237 has been used in only a small number of adults and children, and there is a lot that we do not yet know about this medicine. We have completed a Phase I study in children with cancer. In that study researchers determined the dose of MLN8237 that is well-tolerated in children.

The goals of this study are:
- For patients with solid tumors: to find out if MLN8237 can stop your tumor from growing or cause it to get smaller, for a period of time.
- For patients with leukemia: to find out if MLN8237 can stop leukemia cells from growing or decrease the number of leukemia cells in the body, for a period of time.
- To learn more about the side effects of MLN8237
- To learn more about the pharmacology (how your body handles the drug) of MLN8237.
- To learn more about the biology of MLN8237 (how the drug works in the body and in cells).

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-277
COG ACNS0332: Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Then Average Risk Medulloblastoma/ PNET Patients

The overall goal of this study is to compare the effects, good and/or bad, of the chemotherapy drugs carboplatin and isotretinoin on subjects with high risk medulloblastoma and to find out if one or both are better than standard therapy alone. In this study you will get standard therapy alone, standard therapy plus one of the chemotherapy drugs added to the regimen, or standard therapy plus both of the chemotherapy drugs.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-403
ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML) 

The overall goal of this study is to: · Compare the effects, good and/or bad, of 2 antifungal drugs: caspofungin and fluconazole on people getting treatment for AML, who are at risk of getting invasive fungal infections to find out which is better. In this study, you will get either caspofungin or fluconazole. You will not get both.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-454
COG ACCL0934: A Randomized Trial of Levifloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT): A Groupwide Phase III Study

This study looks at how well treatment with an antibiotic, called levofloxacin can prevent bacterial infection from developing in children and young adults receiving intensive cancer treatment or a stem cell transplant. The levofloxacin treatment to prevent bacterial infection is experimental.

The overall goal of this study is to compare the effects, good and/or bad, of levofloxacin on people receiving intensive cancer treatment or stem cell transplant to find out if it is better than no preventive bacterial infection treatment.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Anjum Zaki
Email: aaz2@georgetown.edu
Phone: 202-687-1351

2011-455***
COG AAML1031: A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD

For subjects without high amounts of the FLT3 gene mutation, 1. To see if an investigational drug, called bortezomib, is tolerated when added to the standard AML treatment without causing too many serious side effects. 2. To compare the effects, good and/or bad, of adding bortezomib to the standard AML treatment to find out which is better. In this study, you will get either the standard treatment plus bortezomib or the standard treatment alone.

For subjects with high amounts of the FLT3 gene mutation,
3. To determine the dose of sorafenib that can be safely given with the standard AML treatment.
4. To compare the effects, good and/or bad, of adding sorafenib to standard AML therapy to find out which is better.
5. To determine how effective the combination of sorafenib and chemotherapy will be at killing cancer cells.

Other goals are:

6. To assess quality of life and parent stress in subjects who receive a stem cell transplant compared with subjects who are treated with chemotherapy.
7. To understand the biology of AML better with the optional biology tests.
8. To compare cure rates and outcomes from patients on this study to patients that participated in previous COG AML studies.
9. To compare any changes in heart function with or without treatment with a drug called dexrazoxane. Dexrazoxane is a drug that is sometimes given to protect the heart. Your doctor will decide if you receive dexrazoxane.

Adding bortezomib to standard chemotherapy is experimental. Adding sorafenib to standard chemotherapy is also experimental.

Lombardi/MedStar Georgetown Hospital

Forms: (coming soon)

  • Protocol
  • HIPAA
  • ICF

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

2011-524
COG AALL1131: Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND #73789, NSC #606869) in the Versy High Risk Stratum: A Groupwide Phase III Study

The purpose of this part of the study is to collect information about your leukemia that will be used to guide further therapy and to understand effects of Induction therapy on you. You have already signed a consent form for the ALL Classification Study AALL08B1, and information gathered on the AALL08B1 will be used to help further define your risk group and guide further therapy. Your doctor will know your final risk group by the end of Induction. You will be offered the chance to continue treatment on other parts of this study once your final ALL risk group is known.

The overall goal of this study is to collect information about your leukemia and about the effects of the first phase of treatment, called Induction.

Your leukemia has been classified as HR-ALL. However, we will know more about your leukemia after you complete Induction chemotherapy. With this new information we will re-classify your leukemia. You will be offered the chance to continue treatment on other parts of this study once your ALL risk group is known after Induction.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Anjum Zaki
Email: aaz2@georgetown.edu
Phone: 202-687-1351

Pro-524
COG ACNS1022: A Phase II Randomized Trial of Lenalidomide (NSC# 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

This study looks at how well lenalidomide works to keep the JPG or OPG from getting worse when given to children, adolescents and young adults with recurrent/refractory/progressive tumors. The use of lenalidomide in children is experimental.

Lenalidomide (brand name Revlimid®) is a drug that is approval by the Food and Drug Administration (FDA) to treat adults who have anemia caused by a condition called myelodysplastic syndrome (MDS) and to treat adults who have a type of cancer called multiple myeloma. It is also being studied in adults with other types of cancers.

Lenalidomide has been used in a study of children with relapsed/refractory cancers and in another study of children with recurrent, refractory, or progressive brain tumors. Results from this second study show that lenalidomide is well-tolerated and appears to have some effect on childhood brain tumors. This study will look at how well two different doses work, by comparing a low dose with a high dose. However, it is not clear if giving a higher dose of lenalidomide has a bigger effect on the tumor.

The overall goal of this study is:
To find out what effects, good and/or bad, a low dose and a high dose of lenalidomide have on children, adolescents and young adults with recurrent/refractory/progressive JPA or OPG.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Lombardi Cancer Line
Contact Email: LombardiCancerLine@gunet.georgetown.edu
Contact Phone: 202-444-4000

Pro-525
COG ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma or Mature B-cell Leukemia: Evaluation of Rituximab Efficacy and Saftey in High Risk Patients.

In summary, the experimental chemotherapy on this study is different from the standard chemotherapy in that:
" The drug rituximab is added to standard chemotherapy for children and adolescents with B-NHL or B-AL.
" Modifications to standard chemotherapy for certain patient groups on study.

The overall goals of this study are to:
" To see if using rituximab in combination with standard chemotherapy versus standard chemotherapy alone will result in improved treatment outcome (for example, a lower likelihood of the disease coming back) for children and adolescents with B-NHL or B-AL.

To find out the important side effects, good and/or bad, of giving rituximab in combination with standard chemotherapy to children and adolescents with B-NHL or B-AL.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Anjum Zaki
Email: aaz2@georgetown.edu
Phone: 202-687-1351