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.
COG D9902: A COG Protocol For Collecting And Banking Soft Tissue Sarcoma Specimens
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.
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.
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.
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.
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.
AHOD04B1: Banking in Hodgkin Disease
The goal of this study is to collect and distribute samples obtained from subjects with Hodgkin Disease.
These samples will be used now and in the future to find out:
- Why some people get Hodgkin Disease;
- Why some people with Hodgkin Disease respond to treatment differently;
- Why some Hodgkin Disease comes back after treatment; and
- Why some people have worse complications from Hodgkin Disease and its treatment.
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.
* CCRN = Childhood Cancer Research Network
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.
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.
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.
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.
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 don't. 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.
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): 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.
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?
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.
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.
COG AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL): A Groupwide 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 group is known.
For more information about this trial from ClinicalTrials.gov, click Additional information on this study from ClinicalTrials.gov
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.
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.
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.
COG 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.
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.
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,
- To see if an investigational drug, called bortezomib, is tolerated when added to the standard AML treatment without causing too many serious side effects.
- 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,
- To determine the dose of sorafenib that can be safely given with the standard AML treatment.
- To compare the effects, good and/or bad, of adding sorafenib to standard AML therapy to find out which is better.
- To determine how effective the combination of sorafenib and chemotherapy will be at killing cancer cells.
Other goals are:
- To assess quality of life and parent stress in subjects who receive a stem cell transplant compared with subjects who are treated with chemotherapy.
- To understand the biology of AML better with the optional biology tests.
- To compare cure rates and outcomes from patients on this study to patients that participated in previous COG AML studies.
- 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.
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 Very 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.
ANBL12P1: Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High-Risk Neuroblastoma.
This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
ANBL1232: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. (Subjects are people who agree to take part in this study.) Subjects will be put into 1 of 3 different treatment groups, labeled as Group A, B and C. The group that you are put in will determine the treatment that you get. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.
Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.
ACNS1221: A Phase II Study for the Treatment of Non-Metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age
Several past studies in Europe have shown that infants with Desmoplastic Medulloblastoma had very good treatment outcomes when treated with the usual chemotherapy drugs; (etoposide, cyclophosphamide, cisplatin and vincristine) in addition to the use of a drug called methotrexate given in high doses into the veins, and into the fluid-containing spaces in the brain (called intraventricular spaces). Other studies In the United States, have shown that infants could do just as well when treated with the usual chemotherapy for medulloblastoma, without using high dose methotrexate.
Giving intraventricular methotrexate can be difficult especially in infants. Studies have also shown that there may be formation of white deposits that may negatively affect the function of the brain (called leukoencephalopathy) which could result in a reduction in thinking and awareness levels (also called neurocognitive impairment) long after treatment has ended. It is thought that this possible bad effect on the brain may be linked to treatment with intraventricular methotrexate. On this study, researchers would therefore like to minimize the risk of this long term bad effect by modifying the treatment given on the European study; giving the usual chemotherapy without using intraventricular methotrexate. To be clear, on this study your child will not receive intraventricular methotrexate (drug delivered directly into the fluid-containing spaces in the brain) but will receive intravenous methotrexate (drug delivered into the vein).
In this study, researchers want to see if giving subjects with Desmoplastic Medulloblastoma this modified therapy will maintain good survival outcomes with little or no side effects.
ARST1321: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
In this study, researchers want to find out if we can improve the treatment for subjects (people who agree to take part in this study) with intermediate and high risk NRSTS by adding an experimental drug called pazopanib to standard therapy.
In adults with certain types of NRSTS pazopanib has been shown to have anti-tumor activity and it is FDA approved for use in adults with certain diseases, including advanced soft tissue sarcoma. Pazopanib has also been used in a small study in children with cancer. Although pazopanib is experimental for use in intermediate and high risk NRSTS, it has been shown to be well tolerated in children and adults. Pazopanib is approved in adults with certain diseases but is considered investigational in children and certain adults. The addition of pazopanib to standard therapy could cause tumor cells to die but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should cause more tumor cells to die and improve survival compared to the usual approach.
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.