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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00006233
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
47
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Drug: mycophenolate mofetil
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the objective response rate in patients with metastatic melanoma treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine and total body irradiation, followed by cyclosporine and mycophenolate mofetil, followed by donor lymphocyte infusion.

  • Determine the disease-free and overall survival of patients treated with this regimen.

  • Determine the toxicity of this nonmyeloablative conditioning regimen in these patients.

OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation on day 0. Allogeneic peripheral blood stem cells are infused on day 0.

Patients receive oral cyclosporine twice a day on days -3 to 35 and tapered until day 56 and oral mycophenolate mofetil 3 times a day on days 0-40.

Patients with mixed chimerism and no graft-versus-host disease on day 56 receive donor lymphocyte infusion (DLI) over 30 minutes on day 65 unless there is evidence of increasing donor chimerism. DLI may be repeated every 65 days for up to 4 doses.

Patients are followed weekly for 3 months, monthly for 6 months, every 6 months through year 2, and then annually through year 5.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4 years.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion in Selected Patients With Metastatic Melanoma
Study Start Date :
Jan 1, 2000
Actual Study Completion Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed stage IV melanoma

    • Partial response, minor response, or stable disease after no more than 2 regimens of chemotherapy, immunotherapy, or chemoimmunotherapy

    • Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging

    • HLA genotypically identical sibling donor available

    • Not an identical twin

    • Age 12 to 74

    • No ocular melanoma

    • No active or untreated brain metastases or transmural gastrointestinal metastases

    PATIENT CHARACTERISTICS:
    Age:
    • 18 to 64
    Performance status:
    • Karnofsky 80-100%
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:

    • Bilirubin no greater than 2 times upper limit of normal (ULN)

    • SGOT and SGPT less than 2 times ULN

    Renal:
    • Creatinine clearance at least 40 mL/min
    Cardiovascular:

    • LVEF at least 40% if history of congestive heart failure

    • No uncontrolled hypertension

    Pulmonary:

    • DLCO at least 50% of predicted

    • No continuous supplementary oxygen

    Other:

    • Not pregnant

    • Fertile patients must use effective contraception during and for 1 year after study participation

    • HIV negative

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • See Disease Characteristics

    • No concurrent growth factors during mycophenolate mofetil administration

    Chemotherapy:
    • See Disease Characteristics
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Not specified
    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1023

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: John A. Thompson, MD, Seattle Cancer Care Alliance

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006233
    Other Study ID Numbers:
    • 1462.00
    • FHCRC-1462.00
    • NCI-G00-1841
    • CDR0000068157
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Nov 30, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Cyclosporine
    Mycophenolic Acid
    Fludarabine
    Fludarabine phosphate
    Cyclosporins

    Study Results

    No Results Posted as of Nov 30, 2011