Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

November 30, 1995

Primary Completion Date

August 31, 2003

Study Completion Date

April 30, 2006

Conditions
MelanomaSkin Cancer
Interventions
BIOLOGICAL

Aldesleukin (IL-2)

Infusion for a total of 96 hours on days 1-4

BIOLOGICAL

Recombinant Interferon Alfa (IFN-A)

"IFN-A Therapy Groups:~Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.~Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks~Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5"

DRUG

Cisplatin

IV Days 1-4

DRUG

Dacarbazine

IVPB on day 1

DRUG

Vinblastine

IVPB on days 1-4

PROCEDURE

Adjuvant Therapy

Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

Trial Locations (1)

77030-4009

University of Texas - MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT00002882 - Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma | Biotech Hunter | Biotech Hunter