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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004135
  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 be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics: Cancer Kidney Cancer Melanoma
Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Filgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy

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

Study Start Date: February 1999
Detailed Description:

OBJECTIVES:

  • Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma.
  • Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population.
  • Determine the efficacy of this treatment regimen in terms of tumor regression, response duration, progression free survival, and overall survival in these patients.
  • Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15 minutes beginning on day 0 and continuing until the target cells are collected. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover.

If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation, patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes. Patients may receive an additional course of donor T lymphocytes at the investigator's discretion.

Patients are followed at days 30 and 100, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery
  • Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI

    • Measurable disease by radiography must be reproducible
    • Bony disease or effusions not measurable
  • No active CNS disease currently receiving radiotherapy or steroids
  • No effusion or ascites of more than 1 liter prior to drainage
  • HLA 5/6 or 6/6 matched sibling donor available

    • No known hypersensitivity to E. coli derived products
    • No active infection
    • No health condition that would preclude donation

PATIENT CHARACTERISTICS:

Age:

  • 18 to 65

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.0 g/dL
  • No active hepatitis

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • LVEF at least 50%

Pulmonary:

  • DLCO at least 50% of predicted

Other:

  • No active infection
  • HIV negative
  • No psychological problem that would preclude study compliance
  • No known hypersensitivity to E. coli derived products
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior systemic chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004135

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Todd M. Zimmerman, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067365, UCCRC-9672, UCCRC-CTRC-9866, NCI-G99-1612
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004135     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Antimetabolites
Urinary Tract Neoplasm
Immunologic Factors
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Melanoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Kidney Diseases
Alkylating Agents
Kidney Cancer
Fludarabine monophosphate
Immunosuppressive Agents
Recurrence
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Carcinoma, Renal Cell
Antineoplastic Agents, Alkylating
Nevus
Fludarabine
Antirheumatic Agents
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Melanoma
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Kidney Diseases
Alkylating Agents
Neoplasms by Histologic Type
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Myeloablative Agonists
Carcinoma, Renal Cell
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 07, 2009