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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004135 |
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 |
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Kidney Cancer Melanoma (Skin) |
Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy |
Study Start Date: | February 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI
HLA 5/6 or 6/6 matched sibling donor available
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Todd M. Zimmerman, MD | University of Chicago |
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 |
stage IV renal cell cancer recurrent renal cell cancer stage IV melanoma recurrent melanoma |
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 |
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 |