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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
mycophenolate mofetil
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006233
Brief Title
Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Thompson, MD
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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