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Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma

NCT00091104 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2012-03-15

No results posted yet for this study

Summary

RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white blood cell infusion may suppress the immune system and allow tumor cells to be killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and aldesleukin and to see how well it works in treating patients with metastatic melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

MART-1:27-35 peptide vaccine

BIOLOGICAL

aldesleukin

BIOLOGICAL

filgrastim

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

therapeutic autologous lymphocytes

BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

DRUG

cyclophosphamide

DRUG

fludarabine phosphate

PROCEDURE

autologous hematopoietic stem cell transplantation

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

RADIATION

total-body irradiation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Steven A. Rosenberg, MD, PhD · NCI - Surgery Branch

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2010-08-31
Completion
2010-10-31

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 NCT00091104 on ClinicalTrials.gov