Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
Drug: Granulocyte-macrophage colony-stimulating factor
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma|
- Objective response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 1998|
|Study Completion Date:||April 2006|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
Experimental: Arm A
CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14.
Other Name: CDDPDrug: dacarbazine
Other Name: DTICDrug: Granulocyte-macrophage colony-stimulating factor
Other Name: GM-CSF
- Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF), interferon alfa, and interleukin-2 in patients with metastatic melanoma.
- Determine the objective response rate, relapse free survival, and overall survival of these patients on this regimen.
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004141
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Study Chair:||Thomas F. Gajewski, MD, PhD||University of Chicago|