IPI Biochemotherapy for Chemonaive Patients 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 Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) 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.
Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Cisplatin is designed to poison the cancer cells, which may cause them to die.
Drug: Interferon Alfa-2b
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma|
- Tumor Response by Participant using immune-related response criteria (irRC) [ Time Frame: End of 2 cycles, 24 weeks ] [ Designated as safety issue: No ]Tumor assessments using irRC modified World Health Organizations (WHO) criteria: Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions. Immune-Related Partial Response (irPR): decrease of 50% or greater. Immune-Related Progressive Disease (irPD): At least 25% increase in sum of products of all index lesions over baseline sum of products of diameters (SPD) calculated for index lesions. Assessment include photographic measurement of skin lesions, computed tomography scans and/or magnetic resonance imaging tumor assessments until documented tumor progression.
|Study Start Date:||February 2013|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab + Chemotherapy
Ipilimumab starting 1 mg/kg by vein (IV) Day 1 each cycle; Temozolomide 200 mg/m^2 orally Days 2-5 of Induction; Cisplatin 25 mg/m^2 IV for Days 2-4 of Induction; Interferon alfa-2b 5 million U/m2 subcutaneously on Days 1-5 of each cycle Induction + Consolidation; and Interleukin-2 9 million IU/m^2 IV as a continuous infusion on Days 2-5 of Induction + Consolidation.
Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.
Phase II dose: Maximum tolerated dose (MTD) from Phase I.
Other Names:Drug: Temozolomide
200 mg/m^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).
Other Name: TemodarDrug: Cisplatin
25 mg/m^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).
Other Names:Drug: Interferon Alfa-2b
5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
Other Name: Intron ADrug: Interleukin-2
9 million IU/m^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409174
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rodabe N. Amaria, MD||M.D. Anderson Cancer Center|