IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma.
Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.
|Melanoma||Drug: Ipilimumab Drug: Interferon Drug: Interleukin-2 (Aldesleukin)||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||IPI-Biotherapy for Patients With Metastatic Melanoma Previously Treated With Cytotoxic Drugs|
- Progression Free survival (PFS) [ Time Frame: Assessed at 6-months then until disease progression or death. ]Progression-free survival determined from the start of the study until disease progression or death, whichever is first and estimated using the method of Kaplan-Meier.
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab + Interferon + Interleukin-2
Ipilimumab starting dose 2 mg/kg intravenous (IV) day 1 only; IFN alfa-2b at 5 million U/m2 subcutaneously daily for 5 days starting day 1; IL-2 at 9 million IU/m^2 daily IV continuous infusion for 4 days on days 2-5.
Starting dose 2 mg/kg by vein on day 1 of each of the four 3-week cycles (Phase II is maximum tolerated dose (MTD) from Phase I). During Consolidation and Maintenance phases one dose every 12 weeks.
Other Names:Drug: Interferon
5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.
Other Names:Drug: Interleukin-2 (Aldesleukin)
9 million IU/m^2 daily by vein by continuous infusion for 4 days (total of 96 hours, days 2-5) starting day 2 of each Induction and Consolidation cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409187
|Principal Investigator:||Agop Y. Bedikian, MD,BS||UT MD Anderson Cancer Center|