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Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00079144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-06-19

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells.

PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

NY-ESO-1 peptide vaccine

BIOLOGICAL

aldesleukin

BIOLOGICAL

filgrastim

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

therapeutic autologous lymphocytes

DRUG

cyclophosphamide

DRUG

fludarabine phosphate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2005-08-31

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 NCT00079144 on ClinicalTrials.gov