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

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ClinicalTrials.gov Identifier: NCT00006233
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 30, 2011
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

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
Melanoma (Skin) 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:


  • 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 Type : Interventional  (Clinical Trial)
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 : January 2000
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 64

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2 times ULN


  • Creatinine clearance at least 40 mL/min


  • LVEF at least 40% if history of congestive heart failure
  • No uncontrolled hypertension


  • DLCO at least 50% of predicted
  • No continuous supplementary oxygen


  • Not pregnant
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • HIV negative


Biologic therapy:

  • See Disease Characteristics
  • No concurrent growth factors during mycophenolate mofetil administration


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006233

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: John A. Thompson, MD Seattle Cancer Care Alliance

ClinicalTrials.gov Identifier: NCT00006233     History of Changes
Other Study ID Numbers: 1462.00
CDR0000068157 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by Fred Hutchinson Cancer Research Center:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fludarabine phosphate
Mycophenolic Acid
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents