Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
Sponsor: Jonsson Comprehensive Cancer Center
Listed as NCT00006968, this PHASE1/PHASE2 trial focuses on Kidney Cancer and remains completed. Sponsored by Jonsson Comprehensive Cancer Center, it has been updated 6 times since 2000, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES: * Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation. * Determine the hematologic and non-hematologic toxic effects of this regimen in these patients. * Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen. OUTLINE: This is a dose-escalation study of pentostatin. * Phase I: Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering. Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive treatment as in phase I at the MTD for pentostatin. Patients are followed weekly for 60 days and then monthly for 10 months. PROJECTED ACCRUAL: A total of 24 patients (12 per phase) will...
OBJECTIVES:
* Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation. * Determine the hematologic and non-hematologic toxic effects of this regimen in these patients. * Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of pentostatin.
* Phase I: Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering.
Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
* Phase II: Patients receive treatment as in phase I at the MTD for pentostatin. Patients are followed weekly for 60 days and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 24 patients (12 per phase) will be accrued for this study.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1/PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
First recorded
Sep 2000
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .