Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma (BCAA)
The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.
- The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.
- To assess responses to the combination.
- To evaluate the duration of response and the overall survival.
- To determine the effectiveness in delaying the appearance of Central Nervous System disease.
Biological: Interferon alpha 2b
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma|
- Response Rate [ Time Frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days). ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Abraxane with Cisplatin, Temozolomide, interleukin-2 and interferon a2b
250 mg/m^2 by mouth on days 1, 2, and 3 of each 21-day cycle.
Other Name: TemodarDrug: Abraxane
100 mg/m^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m^2 given on day 5 of each 21-day cycle.
Other Names:Drug: Cisplatin
20 mg/m^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.
Other Names:Biological: Interleukin-2
9 MIU/m^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.
Other Names:Biological: Interferon alpha 2b
5 MIU/m^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.
Other Name: Intron A
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00970996
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicholas E. Papadopoulos, MD||M.D. Anderson Cancer Center|