Lombardi Comprehensive Cancer Center Clinical Trials Protocol

Cancer Type: Phase I Studies


2009-415

Title: A Phase I Study of LY2801653 in Patients with Advanced Cancer.

Description: 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.

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2010-022

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

Description: 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.

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2010-532

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

Description: 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.

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2010-533

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

Description: This study is for patients with an advanced solid tumor for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, Lapatinib and Bortezomib. Lapatinib is a drug that targets two proteins important for the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins, Lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral pill, given by mouth once every day. Lapatnib is approved by the FDA for patients with breast cancer. Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By inhibiting the proteosome, Bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is approved by the FDA for patients with multiple myeloma and mantle cell lymphoma. This research is being done because it is not known if the combination of Lapatinib and Bortezomib will work better than Lapatinib or Bortezomib alone, although in the lab and in animal studies the combination of the two drugs was much more effective than either drug alone, giving us hope for additional benefit with the combination. As part of this study biopsies will be taken of patients' tumors before any treatment, after starting with the Lapatinib alone, and after receiving both the Lapatinib and Bortezomib. We want to investigate what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.

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

2011-160

Title: 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).

Description: 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.

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

2011-219

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

Description: 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.

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

2011-221

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

Description: This study is for patients with a solid tumor that has gotten worse or has relapsed despite prior treatments.
The purpose of this study is to determine if an investigational drug called cabazitaxel is a safe treatment for patients with advanced cancer who have liver dysfunction. Cabazitaxel will be administered as a 1 hour infusion once every 3 weeks. Subjects will be required to have frequent blood draws during the first 3 weeks only to measure the level of the drug in the blood.

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

2011-345

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

Description: 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.

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2011-385

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

Description: 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.

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

2013-0039

Title: 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.

Description: 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.

Forms:

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

2013-0270

Title: 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.

Description: 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.

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

2013-0342

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

Description: 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.

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

2013-0377

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

Description: 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.

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2013-1442

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

Description: 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.

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Pro-028

Title: A Phase I Study of Intravenous Artesunate in Patients with Solid Tumors.

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

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

Pro-296

Title: 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.

Description: 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.

Forms:

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

Pro-305

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

Description: 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.

Forms:

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

2014-0243

Title: A Phase I, Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158, 2HCL in Patients with Advanced Solid Malignancies.

Description: This study is for patients with advanced solid tumors who have already received standard therapy for their cancer and either did not respond or their cancer came back.

This is the first time the study drug, PFK-158 is being given to humans. The purpose of this study is to determine the safe dose of the drug. PFK-158 is given as an infusion into a vein (intravenously) over 30-90 minutes three times a week for 3 weeks followed by one week with no drug given. This cycle will be repeated until disease progression or intolerable side effects.

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2013-1344

Title: A Phase 1, Open-label, Dose-escalation Study of SNX-5422 and Everolimus in Subjects with Neuroendocrine Tumors

Description: This study will involve treatment with an experimental drug called SNX-5422 mesylate (referred to simply as SNX-5422). An experimental drug is one that has not been approved by the US Food and Drug Administration (FDA) and will not be approved until tests show the drug is safe (will not harm you) and effective (has good results).

The main purpose of this study is to determine the highest dose of SNX-5422 when combined with daily everolimus 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. Everolimus will be taken daily for 28 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.

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2013-1476

Title: MK-3475-029: A Phase I/II clinical trial to study the safety and tolerability of MK-3475 + pegylated interferon alfa-2b (PEG-IFN) and MK-3475 + ipilimumab (IPI) in subjects with advanced melanoma (MEL) and renal cell carcinoma (RCC).

Description: This study is for patients with advanced melanoma or renal cell carcinoma (kidney cancer). Two marketed drugs (PEG-IFN and IPI) will be tested with an experimental drug (MK-3475)

The trial consists of two parts: Part 1 will involve testing different doses of the drugs in combination; Part 2: will involve testing MK-3475 given alone.

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2013-1338

Title: EMR 100070-001: A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects with Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications.

Description: There are two parts to this research trial: a dose escalation part and an expansion part. The main purpose of this research trial is to test MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information and hope to learn which dose (drug strength) could be best for treatment of subjects. Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, we would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research).

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