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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


Phase 2
18 Years
64 Years
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John A. Thompson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance

Authority:

United States: Federal Government

Study ID:

1462.00

NCT ID:

NCT00006233

Start Date:

January 2000

Completion Date:

December 2003

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109