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| Descriptive Information Fields | |||||
| Brief Title † | Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer | ||||
| 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 | ||||
| Brief Summary | RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of cancer 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 system and help destroy any remaining cancer 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. PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study of a conditioning regimen. (Dose escalation completed as of 10/1/03.) Patients receive 1 of 3 dose levels of conditioning chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. (Dose levels 2 and 3 are closed to accrual as of 10/1/03.)
Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary. Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician. Patients are followed every 2 months for 6 months, every 3 months for 2 years, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Graft vs tumor effect by CAT scan at days 30, 60, and 100 following transplant [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Disease-free survival by CAT scan at 6 months and 1 year [ Designated as safety issue: No ] | ||||
| Condition † | Kidney Cancer | ||||
| Intervention † | Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: fludarabine phosphate |
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| MEDLINE PMIDs | 10984562, 14551148 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 80 | ||||
| Start Date † | January 1999 | ||||
| Completion Date | |||||
| Eligibility Criteria † | 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
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003553 | ||||
| Organization ID | CDR0000066610 | ||||
| Secondary IDs †† | NHLBI-97-H-0196 | ||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | June 11, 2008 | ||||