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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005851 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy and radiation therapy together with peripheral stem cell transplant and donor white blood cells and to see how well it works in treating patients with metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: graft-versus-tumor induction therapy Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma |
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV on days -4 to -2 and undergo total body irradiation followed by filgrastim (G-CSF)-mobilized HLA-matched allogeneic peripheral blood stem cell transplantation on day 0.
Patients receive immunosuppressive therapy comprising oral cyclosporine twice daily beginning on day -3 and continuing until day 35 followed by a taper until day 56. Patients also receive oral mycophenolate mofetil three times daily on days 0-40.
Patients with stable mixed chimerism on day 56 and no evidence of graft-vs-host disease may receive escalating doses of nonmobilized T-cell donor lymphocyte infusion (DLI) over 30 minutes. Patients may receive up to 4 DLIs if there is evidence of disease progression.
Patients are followed weekly for 3 months, monthly for 3 months, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV renal cell carcinoma
HLA genotypically identical related donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Colorado | |
| Rocky Mountain Cancer Centers - Denver Midtown | |
| Denver, Colorado, United States, 80218 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000067873, FHCRC-1495.00, NCI-G00-1790 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005851 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer |
|
Antimetabolites Anti-Infective Agents Vidarabine Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid Urogenital Neoplasms Antibiotics, Antineoplastic Urologic Neoplasms Cyclosporins Neoplasms by Site |
Urologic Diseases Kidney Neoplasms Therapeutic Uses Antifungal Agents Mycophenolate mofetil Kidney Diseases Dermatologic Agents Neoplasms by Histologic Type Enzyme Inhibitors Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms |