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Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003552
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma.


Condition Intervention Phase
Stage IV Melanoma
Recurrent Melanoma
Drug: allogeneic lymphocytes
Drug: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: fludarabine
Phase I
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Cyclophosphamide    Fludarabine    Fludarabine monophosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003552

Locations
United States, Maryland
National Heart, Lung, and Blood Institute    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Investigators
Study Chair:     Richard W. Childs     National Heart, Lung, and Blood Institute (NHLBI)    
  More Information


Study ID Numbers:   CDR0000066609, NHLBI-98-H-0006
First Received:   March 1, 2007
Last Updated:   March 1, 2007
ClinicalTrials.gov Identifier:   NCT00003552
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult solid tumor  
body system/site cancer  
cancer  
melanoma  
recurrent melanoma  
skin tumor
solid tumor
stage IV melanoma
stage, melanoma

Study placed in the following topic categories:
Cyclophosphamide
Fludarabine monophosphate
Skin Neoplasms
Recurrence
Melanoma
Neuroendocrine Tumors
Antilymphocyte Serum
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Fludarabine

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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