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Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma


Phase 1/Phase 2
18 Years
60 Years
Not Enrolling
Both
Stage IV Melanoma, Recurrent Melanoma

Thank you

Trial Information

Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma


OBJECTIVES: I. Identify an antitumor effect of allogeneic peripheral blood stem cell
transplantation (PBSCT) in patients with metastatic melanoma.

II. Evaluate the safety and toxicity of a nonmyeloablative, low intensity, preparative
regimen followed by an HLA-matched allogeneic PBSCT in these patients.

III. Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid
lineages in these patients.

IV. Investigate the relationship between donor-host chimerism and the incidence of acute
and chronic graft-versus-host disease in this patient population.

V. Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient
population.

VI. Determine disease-free survival, overall survival, and mortality from the procedure or
tumor progression in this patient population.

PROTOCOL OUTLINE: This is a dose-escalation study of a conditioning regimen. Patients
receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell (PBPC)
transplantation. Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days
-7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1. Patients at dose level
2 receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes
daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2. Patients at dose
level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over
30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.

Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may
be repeated on days 1 and 2 if deemed necessary.

Patients with progressive disease on days 15-30, day 60, or day 100, without
graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor
lymphocyte infusions after day 100 may be given at the discretion of the attending
physician.

Patients are followed every 2 months for 6 months, every 3 months for the next 2 years, and
then every 6 months until year 5 posttransplantation.

PROJECTED ACCRUAL:

A total of 40 patients will be accrued for this study.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed metastatic melanoma not amenable to
complete surgical resection and progressive despite immunotherapy and/or chemotherapy
Bidimensionally evaluable clinically or radiographically HLA 6/6 or 5/6 matched sibling
donor available No CNS metastases --Prior/Concurrent Therapy-- See Disease Characteristics
At least 30 days since prior treatment for melanoma --Patient Characteristics-- Age: 18 to
60 Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 4 mg/dL Transaminases no greater than 3 times
upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Left
ventricular ejection fraction greater than 40% Pulmonary: DLCO greater than 65% of
predicted Other: HIV negative No major organ dysfunction precluding transplantation No
other malignancies except basal cell or squamous cell skin cancer No psychiatric disorder
or mental deficiency that would preclude study Not pregnant or nursing

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard W. Childs

Investigator Role:

Study Chair

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

CDR0000066609

NCT ID:

NCT00003552

Start Date:

January 1999

Completion Date:

October 2002

Related Keywords:

  • Stage IV Melanoma
  • Recurrent Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • melanoma
  • recurrent melanoma
  • skin tumor
  • solid tumor
  • stage IV melanoma
  • stage, melanoma
  • Melanoma

Name

Location

National Heart, Lung, and Blood InstituteBethesda, Maryland  20892