Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery
This study has been terminated.
(Due to a lack of a referal base, study was terminated.)
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00243009
First received: October 20, 2005
Last updated: May 24, 2012
Last verified: June 2010
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Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor 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). 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 transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Drug Information available for:
Fludarabine
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Fludarabine phosphate
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Response rate (complete and partial response) at 6 and 12 months after transplantation [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years [ Designated as safety issue: No ]
- Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years [ Designated as safety issue: No ]
- Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
- Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
- Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
- Toxicity as measured by CTC AE v 3.0 100 days after transplantation [ Designated as safety issue: Yes ]
| Enrollment: | 1 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation, in terms of 6-month and 12-month response rate, in patients with unresectable metastatic renal cell carcinoma.
OUTLINE:
- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation (TBI) on day 0.
- Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo AHSCT on day 0.
- Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81. Patients also receive oral mycophenolate mofetil twice daily on days 0-27 (if patient has a related donor) OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 (if patient has an unrelated donor).
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:
- Clear cell
- Papillary
- Medullary
- Metastatic disease
- Not amenable to curative surgery
- No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
- AST or ALT < 4 times ULN
Renal
- Creatinine clearance > 50 mL/min
Cardiovascular
- LVEF > 35%
- No symptomatic congestive heart failure
Pulmonary
- DLCO > 40% of predicted OR
- Total lung capacity or FEV_1 > 30% of predicted
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 30 days since prior biologic therapy
Chemotherapy
- More than 30 days since prior chemotherapy
Radiotherapy
- More than 30 days since prior radiotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243009
Locations
| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Study Chair: | Brandon M. Hayes-Lattin, MD | OHSU Knight Cancer Institute |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00243009 History of Changes |
| Other Study ID Numbers: | CDR0000447207, OHSU-ONC-03077-L, OHSU-1282 |
| Study First Received: | October 20, 2005 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by OHSU Knight Cancer Institute:
|
recurrent renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Cyclosporins Cyclosporine Mycophenolic Acid |
Mycophenolate mofetil Fludarabine monophosphate Vidarabine Fludarabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013