Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Phase I Studies

Hospitals offering this trial


2009-415
A Phase I Study of LY2801653 in Patients with Advanced Cancer.

People with advanced cancer that has not responded to standard treatment or for which there is no standard treatment are being asked to participate in this study.

The purpose of this study is to test the safety of LY2801653 at different dose levels. We want to find out how LY2801653 is distributed, broken down, and passed out of the body. We want to find out what effects (good and bad) it has on advanced cancer.

Lombardi/MedStar Georgetown Hospital

Forms:

 

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

2010-022

ABT-888 as monotherapy and in combination with Mitomycin C in patients with solid tumors with deficiency in homologous recombination repair.

This study is for patients with any solid tumor who do not have a curative or standard treatment option available. In step 1 of the study previously collected tumor tissue will be tested to find out how efficient the tumor is in repairing damage produced by chemotherapy. This is done by measuring the formation of repair foci, called FancD2 nuclear foci) in tumor samples. Only patients whose tumor has no FancD2 nuclear foci will be eligible for the treatment part of this study, which is step 2.

In step 2 of the study, patients will be assigned to either Arm 1 or Arm 2 treatment. Patients in Arm 1 will receive the investigational drug ABT-888 alone. ABT-888 is a pill that is taken by mouth. Patients in Arm 2 will receive ABT-888 in combination with the standard chemotherapy drug Mitomycin C. Mitomycin C is given by vein.

The purpose of this study is to find out what dose and schedule of the drugs, ABT-888 alone or ABT-888 and Mitomycin C are safe to use in patients with solid tumor cancer. This study will also find out what side effects, good or bad are associated with taking ABT-888 alone or with Mitomycin C. Another purpose of this study is to study how these drugs affect cancer cells. This will be done by doing special laboratory tests on several blood samples taken during the course of the treatment.

Lombardi/MedStar Georgetown Hospital

Forms:

 

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

2010-532
A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of MEDI-565 Adults with Gastrointestinal Adenocarcinomas.

This study is for patients who have a type of cancer of the esophagus, stomach, gall bladder, pancreas, colon or intestinal tract (gastrointestinal or GI cancer) that has not reposnded well to available (standard) cancer therapies oR is a cancer for which no standard therapy exists.

Most types of GI cancwer produce a protein called carcinoembryonic antigen (CEA). This protein is found or expresssed on the outside of most types of GI cancer cells and is also released into the blood stream. The CEA level helps doctors to know how much or how little caancer cells may be growinig. High amounts or a high level of CEA has been seen in those patients that have colorectal, pancreatic, and gastric cancers.

MEDI-565 is an experimental drug being tested in humans for the first time. MEI-565 is a small protein that binds to both the CEA on GI cancer cells and to other cells in the immune system called T cells. These T cells then direct the immune system to kill these cancer cells that express CEA before they grow into more cancer cells.

The main purpose of this study is to determine the dose of MEDI-565 that is safe and tolerable in patients with GI cancers. This study will also evaluate (1) how much MEDI-565 is in the blood at various times, (2) whether the body procuces antibodies (proteins produced by your immune system) against MEDI-565, and (3) the anti-cancer effect of MEDI-565. Thi study will also look at th effect of MEDI-565 on other cells or protein markers that might be related to cancer.

Lombardi/MedStar Georgetown Hospital

Forms:

 

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

2010-533
A Phase I Study of the HER1, HER2 Dual Kinase Inhibitor Lapatinib plus the Proteasomal Inhibitor Bortezomib in Patients with Advanced Malignancies.

This is a single-arm, open label Phase I study to evaluate the safety and clinical activity of the combination of the FDA-approved HER1, HER2 small molecule inhibitor, lapatinib, with the FDA-approved proteosome inhibitor, bortezomib in patients with advanced malignancies. Subjects with metastatic, unresectable cancer, whose disease has progressed on, or who were intolerant of, or ineligible for all standard therapies, but still have an adequate performance status and normal hepatic and renal function will be eligible. We will perform a standard 3+3 dose escalation study beginning at a reduced dose of both agents. The starting dose of lapatinib will be 1000 mg/day continuously for 28 days of each 28 day cycle, including an initial run-in of lapatinib alone (the run-in dose will be started on day -7). Subjects will also receive bortezomib IV on days 1, 8, and 15 of a 28 day cycle. The starting dose of bortezomib will be 1.0 mg/2. Patients will be enrolled in a standard 3+3 alternating dose escalating fashion to a maximal dose of lapatinib of 1500 mg/day and a maximal dose of bortezomib of 1.6 mg/m2. Subjects will be enrolled in cohorts of three. If there are no dose limiting toxicities (DLT) in the first cohort, then three subjects will be enrolled in the next cohort. Intra-patient dose escalation will not be allowed. If one subject in any cohort experiences a DLT, then the cohort will be expanded to 6 subjects. If no additional subjects experience a DLT, then 3 subjects will be enrolled in the next cohort. If 2/ 6 or greater of the subjects experience a DLT, then the dose level below will be considered the maximum tolerated dose (MTD). A minimum of 6 subjects will be enrolled at the expected MTD dose level before the MTD can be declared. Dose de-escalation contingencies have also been included. If 2/ 6 or greater of the subjects at Dose level 1 experience a DLT, then subjects will be enrolled at Dose level -1. If 2/ 6 or greater of the subjects at Dose level -1 experience a DLT, then subjects will be enrolled at Dose level -2. If 2/ 6 or greater of the subjects at Dose level -2 experiences a DLT, then the trial will be terminated. Once the recommended Phase II dose (RP2D) is established, an additional 10 subjects will be treated at the RP2D to provide a more confident assessment of safety and tolerability, and to provide a preliminary assessment of treatment efficacy. Dose limiting toxicity (DLT) will be defined as any of the following events that are possibly, probably, or definitely related to one or both agents and occur within the first cycle of therapy: - Grade 4 neutropenia lasting greater than 5 days or complicated by fever or infection. - Grade 4 anemia or thrombocytopenia - Grade 3 or 4 non-hematologic toxicity. For subjects with baseline grade 2 elevated liver enzymes due to known intrahepatic metastases, the DLT will be defined only as a grade 4 elevation of AST, ALT, total bilirubin, or alkaline phosphatase. - Any toxicity regardless of grade, which results in withholding of therapy for greater than 3 weeks The maximally tolerated dose (MTD) will be defined as the dose level one level below the dose level at which 2 or more subjects out of 6 experiences a DLT of one or both agents. The recommended Phase 2 dose (RP2D) will be defined as the same dose level (or lower) as the MTD. The RP2D may be lower than the MTD, based on correlative, biomarker studies, or based on concurrent study publications, at the discretion of the investigators. Response will be assessed using RECIST 1.1 criteria. Subjects will be evaluated, including laboratory testing every two weeks until the first restaging analysis. Restaging will occur after 2 cycles (approximately every 8 weeks). If at restaging there is no evidence of progression of disease and the subject is tolerating therapy, then subjects may be seen every 4 weeks, unless clinically indicated. Subjects will remain on study as long as there is no evidence of progression of disease (according to RECIST 1.1 criteria) and the therapy is adequately tolerated. Correlative studies: An additional scientific objective is to assess the pharmacodynamic effects of lapatinib alone, and in combination with bortezomib on the HER1 and HER2 pathways, and pathways known to be affected by/ related to proteosomal inhibition by phosphorylation pathway analysis, and to correlate those effects to the response rate. Thus, all subjects are required to have the following serial biopsies: - A fresh biopsy prior to treatment - A repeat biopsy after single agent lapatinib - A final biopsy after combination therapy with lapatinib and bortezomib The first biopsy can be performed anytime between screening and lapatinib dosing. The Day 1 and Day 5 biopsies may be performed up to 24 hours before. For this reason, subjects will be screened for accessibility of tumor tissue. Specifically, our radiologist will review the most recent images for each subject prior to enrollment. Only subjects, who in his best estimation, have tumor that is easily accessible by ultrasound (preferred) or CT guidance in order to obtain serial core needle biopsies will be eligible for this study. Three core biopsy specimens will be collected in formalin,liquid nitrogen, and a Proprietary Universal Fixative, developed by Theranostics Health to block fluctuation in kinases and phosphatases. Phosphoprotein (phosphoproteomic) testing and analysis will be performed as a joint collaboration with Theranostics Health in Rockville, MD. Peripheral blood will be collected for serum and peripheral blood mononuclear cells on the same days biopsies are taken. Pharmacokinetics (PK): Extensive PK assessment of both agents will be performed. Subjects in the expansion cohorts will not undergo PK analysis. To assess the PKs of lapatinib alone, lapatinib will be started on Day -7. Blood sampling will be performed at 0, 2, 4, 8, and 24 hours on Days -7. On Day 1, a lapatinib trough level will be drawn, then subjects will receive their dose of lapatnib, followed immediatly by an IV dose of bortezomib. Blood sampling will be performed at 2, 4, 8, and 24, and 86 hours hours. Additionally, a lapatinib trough level and bortezomib level will be drawn on Day 8.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Rose Hardesty
Email: rk286@georgetown.edu
Phone: 202-687-2111

2011-160
A Phase I Study of PF-05082566 as a Single Agent in Patients with Advanced Cancer, and in Combination with Rituximab in Patients with Non-Hodgkin's Lymphoma (NHL).

This study is for patients with advanced cancer that is no longer responsive to standard anti-cancer therapies. The purpose of this study is to learn about the effects of the study drug, PF-05082566, and to find out the best dose for treating solid tumors and/or B-cell lymphoma (Part A) and Non-Hodgkin?s lymphoma (Part B). In Part B, PF-05082566 will be given together with rituximab. PF-05082566 is a new investigational drug. An investigational drug is one that is currently not approved for sale in this country. PF-05082566 is an antibody, which is a type of protein, which has been shown in animal studies to stimulate the immune system. It is given as a 1 hour intravenous infusion once every 28 days. This will be the first time that PF-05082566 is being studied in humans.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Rose Hardesty
Email: rk286@georgetown.edu
Phone: 202-687-2111

2011-219
A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients with Advanced, Refractory Colorectal Cancer.

This study is for patients with metastatic colorectal cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with metastatic colorectal cancer. PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevents cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in your body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for colorectal cancer.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Lisa Ley
Email: leyl@georgetown.edu
Phone: 202-687-6653

2011-221
Phase 1 Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) in Advanced Solid Tumor Patients with Varying Degrees of Hepatic Impairment.

This study is designed as an open-label, dose-escalation, multi-center study of cabazitaxel in cancer patients with varying degrees of hepatic impairment. Subjects will be enrolled in 4 cohorts based on hepatic function graded by total bilirubin and aspartate aminotransferase (AST). Cohorts 1 and 5 will be patients with normal hepatic function; Cohort 2 mild hepatic impairment; Cohort 3 moderate hepatic impairment; and Cohort 4 severe hepatic impairment. All liver function tests must be completed within 48 hours prior to the start of treatment, and reviewed by the investigator or his designee before treatment administration. Cohort 5 is a single sequence, two-treatment crossover (midazolam without vs. with cabazitaxel 25 mg/m2) crossover study with 24 hours between the two midazolam treatments. Midazolam will be administered orally as a single dose on Day -1 and Day 1 to subjects in cohort 5 only. Six subjects will be enrolled in Cohort 1 and 12 subjects in Cohort 5, there will be no dose escalation for Cohorts 1 and 5. Cohorts 1, 2 and 5 may enroll subjects simultaneously. Cohort 3 will be initiated after at least 3 subjects in Cohort 2 complete the first cycle of treatment with no dose-limiting toxicities (DLTs) being observed. Similarly, Cohort 4 may begin after 3 subjects complete the first cycle of Cohort 3, providing no DLT has occurred. The dose escalation for Cohorts 2, 3, and 4 are shown in the tables on Page 38 of the protocol document. Samples for pharmacokinetic (PK) analysis will be collected from all subjects in each cohort, at each dose level, during Cycle 1 only. Real time PK information will be used to inform the dose selection in the next dose level for Cohorts 3 and 4 and the starting dose of Cohort 4 along with safety information. For each cohort, the dose escalation criteria as described below must be met at each dose level following Cycle 1 in order to enroll and treat additional subjects at the next dose level. For Cohorts 2, 3, and 4, a 1 week gap is required between the treatment of each subject for the first 3 subjects in each dose level to allow for safety evaluation. If 0 of the first 3 subjects have a Cycle 1 DLT at a given dose level: escalate dose level and enter at least 3 subjects at the next dose level (Cohorts 2-4) or at the same dose level (Cohort 1). If 1 out of the first 3 subjects has a Cycle 1 DLT at a given dose level: enter up to 3 additional subjects at this dose level. If 0 of the 3 additional subjects experience a DLT then proceed to the next higher dose level to a maximum dose of 25 mg/m2. If 1 or more of the 3 additional subjects experience a DLT, then dose escalation will be stopped. Decrease dose to the next available dose level. If a lower dose is not available, enrollment will be stopped for a given cohort. If 2 of the first 3 subjects have a Cycle 1 DLT at a given dose level: Decrease the dose to the next available lower dose level. If a lower dose level is not available, enrollment will be stopped for a given cohort. To be considered a FLT, the clinical adverse event or laboratory abnormality should be drug-related as assessed by the investigator. Liver DLTs in subjects with hepatic dysfunction (Cohorts 2, 3 and 4) will be defined as an increase in total and direct bilirubin and/or transaminase levels to 3 times the baseline value. In addition, a treatment delay due to cabazitaxel related toxicity of 2 weeks between cycles is considered a DLT. All other DLTs will be defined (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 grading scale) during the first treatment cycle, as follows: 1) Non-hematological toxicity Grade 3 or 4 except: - Grade 3 fever without documented infection - Grade 3 nausea and vomiting in the absence of effective maximal anti-emetic therapy - Grade 3 mucositis/stomatitis in the absence of effective symptomatic treatment - Grade 3 fatigue - Grade 3 anorexia - Grade 3 AST/ALT or bilirubin elevation that returns to baseline prior to next treatment cycle (Cohort 1 only) - Grade 3 hypersensitivity reaction in the absence of required premedication - Peripheral neuropathy Grade 3 that returns to Grade 2 or less at the initiation of the next treatment cycle 2) Hematological toxicity defined as: - Febrile neutropenia: Fever with Grade 3 or 4 neutropenia - Grade 4 neutropenia lasting > 7 days - Grade 4 thrombocytopenia The maximum administered dose (MAD) of Cohort 2, 3, and 4 will be reached at the dose level when at least 2 subjects develop a DLT during the first cycle. Subjects who are not treated, or are withdrawn during the first 3 weeks of treatment, for reasons other than DLT and before the MAD is determined, will be replaced. Prophylactic and therapeutic use of hematopoietic growth factors is not permitted during the first cycle of study treatment unless a hematological DLT is encountered. The maximal tolerated dose (MTD) will be defined as the highest dose at which 0 of the first 3 subjects, or 1 of 6 subjects experience a DLT during the first cycle of cabazitaxel to a maximum dose of 25 mg/m2. The MTD is one dose level below the MAD. It is anticipated that up to 12 subjects will be treated at the MTD for Cohort 2 and up to 6 subjects will be treated at the MTD for Cohorts 3 and 4 in order to obtain sufficient sample to evaluate the safety and PK profile. If the MAD is reached at 5 or 10 mg/m2 (Cohorts 3 and 4), then no subjects will be further enrolled as the MTD could not be established. There will be no dose recommendation for such subject population. Vital signs, medical history, physical examination, Eastern Cooperative Oncology Group (ECOG) performance status, electrocardiogram, and laboratory safety tests (including hematology, serum chemistries, and urinalysis) will be obtained prior to study drug administration and at designated intervals throughout the study. Treatment-emergent adverse events will be collected during the study and up to 30 days after the end of the study treatment. Any serious adverse events considered related to the study medication will be collected regardless of when they occur. Adverse events will be graded according to the NCI CTCAE v. 4.0. For Cohorts 1-4: Blood samples (2 mL) each for pharmacokinetic analyses will be collected from all subjects at Cycle 1, Day 1, before the start of infusion, 5 minutes before the end of the infusion, and then 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 5 hours, 7 hours and 10 hours post-infusion and on Day 2 (approximately 24 hours), Day 3 (approximately 48 hours), Day 4 (approximately 72 hours), Day 5 (approximately 96 hours), Day 8 (approximately 168 hours) and Day 10 (approximately 216 hours) after the end of infusion. In addition on Day 1 and 2 of Cycle 1, blood samples will be collected from all subjects for the determination of the free fraction (protein binding) of cabazitaxel before the start of infusion, 5 minutes before the end of infusion and then 3 and 24 hours after the end of infusion. For Cohort 5: Blood samples (2 mL each) for cabazitaxel will be collected on Cycle 1 Day 1 before the start of infusion, 5 minutes before the end of infusion, and then 5 minutes, 15 minutes, 1 hour, 3 hours, 10 hours, 24 hours, and 168 hours (Day 8) after the end of the cabazitaxel infusion. Blood samples (3 mL each) for midazolam PK analysis will be collected on Cycle 1, Day -1 and Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. Efficacy assessment and schedule will be at the investigator?s choice and per local practice. No efficacy data will be collected for the study.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Ion Cotarla
Email: ic34@georgetown.edu
Phone: 202-687-4510

 

2011-345
A Phase 1 Study of a Combination of the Peroxisome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene

This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. Both these drugs have many effects on cancer cells, including stopping cancer cell growth and division, and causing the cancer cells to die. They work on cancer cells in a similar manner and both drugs together may have even a greater effect against cancer cells, hopefully increasing the killing of cancer cells.

CS-7017 is an investigational or experimental anti-cancer agent that as not been yet approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved for patients with a specific type of cancer, cutaneous T-cell lymphoma.

This study will help find out what effects the combination of drugs has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.

 

Forms:


 

2011-385
A Phase I, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects with Relapsed or Refractory Advanced Solid Malignanices.

This study is for patients with an advanced cancer. This research is being done to help understand the best dose of I-131-CLR1404, the study drug, how it circulates in the body, how much radiation is delivered to the normal organs of the body and to the cancer, what the side effects of the drug are and how effective the drug is against cancer. I-131-CLR1404 is a radiopharmaceutical cancer therapy, which means there is radiation in I-131-CLR1404. It is thought that I-131-CLR1404 is attracted to cancer cells more than healthy cells and because of this, the cancer cells take in most of the radiation (and are then killed by the radiation) and leaves most of the healthy cells alone. The use of I-131-CLR1404 is investigational. This means that I-131-CLR1404 is not approved for marketing by the U.S. Food and Drug Administration (FDA). The FDA is allowing the use of I-131-CLR1404 in this study.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Jim Leucht
Email: jjl99@georgetown.edu
Phone: 202-687-5791

2013-0039
A Phase I Study of the BCR-ABL Tyrosine Kinase Inhibitor Nilotinib and Cetuximab in Patients with Solid Tumors that can be Treated with Cetuximab.

The purpose of this study is to determine the recommended Phase II dose of nilotinib when used in combination with cetuximab in the treatment of patients with recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Ion Cotarla
Email: ic34@georgetown.edu
Phone: 202-687-4510

2013-0270
CA209-004: A Phase 1b, Open-Label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 (BMS-936558) in Combination with Ipilimumab (BMS-734016) in Subjects with Unresectable Stage III or Stage IV Malignant Melanoma.

The purpose of this study is to test the safety and efficacy of taking BMS-936558 and ipilimumab together to treat melanoma that is resistant or recurrent.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact : Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007

 

2013-0342
A Phase 1, Open-label, Dose-escalation Study of SNX-5422 plus Carboplatin and Paclitaxel in Subjects with Selected Solid Tumors

This study is for patients with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)

The main purpose of this study is to determine the highest dose of SNX-5422 when combined with once every 3 weeks of both carboplatin and paclitaxel that can be tolerated when SNX-5422 is given once every other day for 21 days followed by a 1-week period (7 days) without study drug. SNX-5422 is an experimental drug that has not yet been approved by the US Food and Drug administration. Carboplatin and paclitaxel will be given as an IV infusion (through a needle in a vein) once every 3 weeks for a maximum of 4 times through the first 3 cycles of SNX-5422. After that SNX-5422 will be given alone as long as the lung cancer is not getting worse and the drug is tolerated without bad side effects. Other goals of this study are to study its side effects, to measure its possible effects on the tumor, and to further study how this drug works.
Forms:

Contact: Erica Sondergaard
Email: els71@georgetown.edu
Phone: 202-687-1116


2013-0377
A Single Arm Study of SNX-5422 in Subjects with Selected HER2 Positive Cancers.

This study will involve treatment with an experimental drug called SNX-5422 mesylate (referred to simply as SNX-5422). The main purpose of this study is to determine the highest dose of SNX-5422 that can be tolerated when given once every other day for 21 days. Other goals of this study are to study its side effects, to measure its possible effects on the tumor, and to further study how this drug works.

Forms:


2013-1442
Merck 028: Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors.

This study is for patients with an advanced solid tumor that has failed prior treatment or for which no standard treatment exists.

The main purpose of this study is to:

  • Test the safety and tolerability of the research study drug, MK-3475.
  • To see if MK-3475 has anti-tumor activity in advanced solid tumors.

All subjects will receive MK-3475 as an intravenous infusion (through a needle in a vein) once every 2 weeks.

Forms:


 

Pro-028
A Phase I Study of Intravenous Artesunate in Patients with Solid Tumors.

The purpose of this project is to determine the safety, rolerability, and maximum tolerated dose (MTD) of intravenous artesunate in patients with solid tumors.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Christi Fasano
Email: ccf42@georgetown.edu
Phone: 202-687-2007

 

Pro-296
GP28328: A Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered with Bevacizumab or with Bevacizumab plus FOLFOX in Patients with Advanced Solid Tumors.

This study is for patients with cancer that is locally advanced or metastatic (grown or spread) that did not respond to previous treatment(s) or for which previous treatment(s) was stopped because the side effects were not tolerable. Patients with metastatic colorectal cancer that has not been previously treated with oxaliplatin may also take part in this study.

The purpose of this study is to find out whether an investigational drug called MPDL3280A can be safely used in combination with the standard drug bevacizumab or bevacizumab plus FOLFOX chemotherapy.

The body's immune system has a certain natural ability to withstand tumor growth. Tumors partially resist the immune system using the PF-L1 pathway. By blocking the PD-L1 pathway, MPDL3280A may help the immune system to withstand the growth of tumors.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Christi Fasano
Email: ccf42@georgetown.edu
Phone: 202-687-2007

 

Pro-305
CD-ON-MEDI4736-1108: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors.

This study is for subjects with a type of cancer (or tumor) of the skin, kidney, lung, or colon that has not responded well to available (standard) therapies or for which no standard therapy exists.

MEDI4736 is an antibody that is made in the laboratory. An antibody is a natural protein made by the immune system that binds other proteins and molecules to fight infection and other foreign bodies (such as cancer). MEDI4736 is an experimental drug being tested in humans for the first time. MEDI4736 binds to another protein in the body and may prevent cancer growth by helping certain blood cells of the immune system eliminate the tumor.

The main purpose of this study is to determine the dose of MEDI4736 that is safe and tolerable in subjects with solid tumors. This study will also evaluate how much MEDI4736 is in the blood at various times, whether the immune system becomes activated following treatment or the body produces antibodies (proteins produced by your immune system) against MEDI4736, as well as the effect MEDI4736 has on cancer.

Lombardi/MedStar Georgetown Hospital

Forms:

 

Contact: Ion Cotarla
Email: ic34@georgetown.edu
Phone: 202-687-4510