Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003553 |
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop 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 with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy |
Estimated Enrollment: | 80 |
Study Start Date: | January 1999 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Preparative regimen 1: Experimental
Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1.
|
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
|
Preparative regimen 2 (closed to accrual as of 10/1/03): Experimental
Patients receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to
|
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
|
Preparative regimen 3 (closed to accrual as of 10/1/03): Experimental
Patients receive cyclophosphamide IV over 1 hour on days -8 to -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to -2.
|
Biological: anti-thymocyte globulin
Given IV
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
|
GVHD regimen 1 (closed to accrual as of 10/17/00): Experimental
Patients receive cyclosporine IV over 12 hours or orally beginning on day -4 and continuing for up to approximately 3 months.
|
Drug: cyclosporine
Given IV
|
GVHD regimen 2 (open to accrual from 10/17/00 through 2/11/02): Experimental
Patients receive cyclosporine as in regimen 1. Patients also receive mycophenolate mofetil.
|
Drug: cyclosporine
Given IV
Drug: mycophenolate mofetil
Given as GVHD prophylaxis
|
GVHD regimen 3 (open to accrual as of 2/11/02): Experimental
Patients receive cyclosporine as in regimen 1. Patients also receive methotrexate.
|
Drug: cyclosporine
Given IV
Drug: methotrexate
Given as GVHD prophylaxis
|
OBJECTIVES:
OUTLINE:
Nonmyeloablative preparative regimen: Patients receive 1 of 3 preparative regimens prior to peripheral blood progenitor cell (PBPC) transplantation. (Regimens 2 and 3 closed to accrual as of 10/1/03.)
Graft-versus-host disease (GVHD) prophylaxis: Patients receive 1 of 3 GVHD prophylaxis regimens.
Patients also receive mycophenolate mofetil.
Regimen 3 (open to accrual as of 2/11/02): Patients receive cyclosporine as in regimen 1. Patients also receive methotrexate.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Patient Recruitment 800-411-1222 |
Study Chair: | Richard W. Childs, MD | National Heart, Lung, and Blood Institute (NHLBI) |
Responsible Party: | National Heart, Lung, and Blood Institute ( Richard W. Childs ) |
Study ID Numbers: | CDR0000066610, NHLBI-97-H-0196 |
Study First Received: | November 1, 1999 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00003553 History of Changes |
Health Authority: | Unspecified |
stage IV renal cell cancer recurrent renal cell cancer |
Antimetabolites Anti-Infective Agents Urinary Tract Neoplasm Cyclosporine Immunologic Factors Folate Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Cyclosporins Vitamin B9 Renal Cancer Urologic Diseases Kidney Neoplasms Antifungal Agents |
Mycophenolate mofetil Methotrexate Kidney Diseases Alkylating Agents Kidney Cancer Fludarabine monophosphate Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Recurrence Carcinoma Folic Acid Antilymphocyte Serum Carcinoma, Renal Cell Fludarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Reproductive Control Agents Cyclophosphamide Urologic Neoplasms Cyclosporins Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Antifungal Agents Therapeutic Uses Abortifacient Agents Mycophenolate mofetil Methotrexate Kidney Diseases Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Enzyme Inhibitors Fludarabine monophosphate Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |