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

NCT00002882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-12-13

No results posted yet for this study

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.

Conditions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Agop Y. Bedikian, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-11-30
Primary Completion
2003-08-31
Completion
2006-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002882 on ClinicalTrials.gov