Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma (BCAA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00970996|
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : January 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Temozolomide Drug: Abraxane Drug: Cisplatin Biological: Interleukin-2 Biological: Interferon alpha 2b||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Biochemotherapy With Cisplatin, Temozolomide, With Increasing Doses of Abraxane, Combined With Interleukin-2 and Interferon in Patients With Metastatic Melanoma|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- Response Rate [ Time Frame: Radiographic studies (CT, MRI scans) to assess disease response after every two cycles (one cycle=21 days). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|