Clinical Trial NCI UPMC14M01
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- Principal Investigator
- Timothy Kuzel
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NCI UPMC14M01
- The purpose of this study is to see whether the combination of the two drugs aflibercept and interleukin-2 (IL-2) will help prevent the growth of your cancer. This study is being done to see if giving IL-2 and aflibercept together (in combination) is more effective in treating your cancer (metastatic melanoma) than IL-2 or aflibercept given by themselves. This study is also being done to look at the severity of the side effects caused by this combination treatment.
- IL-2 is approved by the Food and Drug Administration for the treatment of melanoma. Aflibercept (also called VEGF Trap) is an investigational or experimental anti-cancer drug. That means it has not been approved by the Food and Drug Administration for use in patients with melanoma. The development of new blood vessels is essential for tumors to grow and survive. Vascular endothelial growth factor (VEGF) is an important molecule which drives angiogenesis (the formation of new blood vessels). The experimental drug aflibercept inactivates VEGF from functioning and scientific experiments have shown that when VEGF is prevented from working, new blood vessels don’t form in tumors and these tumors do not grow. Aflibercept has been used to treat patients with various types of cancers. Some patients with melanoma, lung, ovarian, bladder or kidney cancer have responded well to VEGF Trap. In addition, there is scientific evidence that supports the combination of aflibercept with interleukin-2, so this drug will now be evaluated in combination with interleukin-2 in patients with melanoma.
Some of the eligibility criteria include:
- Participants in this study must have metastatic melanoma.
- Participants may have had up to two prior treatment regimens for their metastatic melanoma.
- Participants must be 16 or older.
- Description of Treatment
- Participants will be randomly assigned to either Arm A or Arm B. For participants in Arm A aflibercept will be administered intravenously (through a vein in the arm). It will be repeated every 2 weeks as long as the cancer has not progressed and the doctor determines it is safe to continue aflibercept. IL-2 therapy will also be given intravenously (into a vein). IL-2 will be given for a maximum of 6 cycles. For each cycle of IL-2, participants will be admitted to the hospital to receive IL-2 every 8 hours for 5 days (a maximum of 14 doses). For participants in Arm B IL-2 will be given according to the standard of care for the treatment of melanoma. IL-2 is given intravenously (into a vein). Participants will receive a maximum of 3 courses, or 6 cycles.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
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last updated: 31-Oct-14 01:47 AM
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