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Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma

NCT00303836 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-06-06

No results posted yet for this study

Summary

This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy with interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma.

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma

Interventions

DRUG

cyclophosphamide

Given IV

DRUG

fludarabine phosphate

Given IV

BIOLOGICAL

therapeutic autologous lymphocytes

Given IV

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

Undergo in vitro-treated peripheral blood stem cell transplantation

BIOLOGICAL

gp100 antigen

Given SC

BIOLOGICAL

MART-1 antigen

Given SC

BIOLOGICAL

incomplete Freund's adjuvant

Given SC

BIOLOGICAL

filgrastim

Given SC

BIOLOGICAL

aldesleukin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven Rosenberg · National Cancer Institute Surgery Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00303836 on ClinicalTrials.gov