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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025519 |
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Drug: thalidomide Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: Patients are stratified according to risk (low vs high).
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1. Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease (GVHD) prophylaxis. Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0.
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions (DLI) on days 60, 90, and 120. Patients may receive additional DLI as needed. Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD.
Patients are followed at 1, 3, 6, and 12 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients (10-20 per stratum) will be accrued for this study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma (RCC)
Prior debulking nephrectomy required
Must have HLA-identical donor
Matched related sibling donors must have 6/6 serologic HLA A, B, and DR match with molecular confirmation at DRB1
No brain metastases
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, Pennsylvania | |
Fox Chase - Temple Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2442 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Study Chair: | Gary R. Hudes, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068970, FCCC-01006, TUHSC-3721, NCI-G01-2021 |
Study First Received: | October 11, 2001 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00025519 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer clear cell renal cell carcinoma |
Thalidomide Urogenital Neoplasms Tacrolimus Fludarabine monophosphate Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Mycophenolate mofetil Carcinoma, Renal Cell Fludarabine Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |