Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| 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| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1023 | |
| Study Chair: | John A. Thompson, MD | Seattle Cancer Care Alliance |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006233 History of Changes |
| Other Study ID Numbers: | 1462.00, FHCRC-1462.00, NCI-G00-1841, CDR0000068157 |
| Study First Received: | September 11, 2000 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclosporins Cyclosporine Mycophenolic Acid Mycophenolate mofetil Fludarabine monophosphate Vidarabine Fludarabine |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013