Pilot Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Hormone-Refractory Prostate Cancer
OBJECTIVES:
- Determine the treatment-related mortality in patients with hormone-refractory,
progressive metastatic prostate cancer treated with nonmyeloablative conditioning
comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic
stem cell transplantation.
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 10 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of adenocarcinoma of the prostate
- Metastatic and progressive disease
- Refractory to hormonal therapy
- Prostate-specific antigen (PSA) > 5 ng/mL
- Previously treated with a docetaxel-based regimen
- 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 and 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
Other
- HIV negative
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- See Disease Characteristics
PATIENT AND DONOR SELECTION CRITERIA
4.1 Patient
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality as measured by Kaplan-Meier at 5 years following transplant
No
Brandon M. Hayes-Lattin, MD
Study Chair
Oregon Health and Science University
United States: Federal Government
CDR0000447211
NCT00242931
January 2005
March 2008
Name | Location |
---|