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Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma

NCT00006233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-11-30

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation, peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

therapeutic allogeneic lymphocytes

DRUG

cyclosporine

DRUG

fludarabine phosphate

DRUG

mycophenolate mofetil

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • John A. Thompson, MD · Seattle Cancer Care Alliance

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Completion
2003-12-31

Countries

  • United States

Study Locations

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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 NCT00006233 on ClinicalTrials.gov