Flu/TBI in Treating Patients Not Responding to Previous Hormone Therapy
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
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 Inclusion Criteria: 4.1.1 Males aged 18-75. 4.1.2 Pathologically proven adenocarcinoma of the prostate with metastases and progressive disease (new metastatic lesions or increase in cancer-related pain or a rising PSA defined by consensus criteria. (A rising PSA will be defined as 2 measurements higher than an initial value. The second of the 3 measurements must be at least 7 days after the first). 4.1.3 Progressive disease despite hormonal management (including antiandrogen withdrawal, 6 weeks for bicalutamide, 4 weeks for flutamide or nilutamide) 4.1.4 PSA > 5 ng/mL 4.1.5 Serum testosterone level < 50 ng/mL 4.1.6 Prior treatment with a docetaxel-based regimen. 4.1.7 Performance status: Karnofsky Performance Scale (KPS) 70-100%. (Appendix III). 4.1.8 Signed informed patient consent. 4.2 Patient Exclusion criteria: 4.2.1 Expected survival less than 6 months 4.2.2 Active central nervous system involvement or spinal instability 4.2.3 Organ dysfunction: 4.2.3.1 Cardiac: Ejection fraction <35% or symptomatic congestive heart failure. 4.2.3.2 Pulmonary: DLCO <40% of predicted or either TLC or FEV1 < 30% predicted. 4.2.3.3 Liver dysfunction: serum total bilirubin >2x upper limit of normal (ULN) or either ALT or AST >4x ULN 4.2.3.4 Renal dysfunction: creatinine clearance < 50 ml/min 4.2.4 HIV seropositivity 4.2 Related Donor Inclusion criteria: 4.3.1 Age 18-75 4.3.2 Related to the patient and genotypically or phenotypically HLA-identical. (Appendix IV) 4.3.3 Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow donors are not eligible. 4.3 Unrelated Donor Inclusion criteria: 4.4.1 Age 18-75. 4.4.2 Unrelated donors who are prospectively: 4.4.2.1 Matched for HLA-DRB1 and -DQB1 alleles by high resolution typing AND 4.4.2.2 Matched for all serologically recognized HLA-A or -B or -C antigens and at least five of six HLA-A or -B or -C alleles as defined by Appendix IV. 4.4.3 Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow unrelated donors are not eligible. 4.4 Related and Unrelated Donor Exclusion criteria: 4.5.1 Identical twin. 4.5.2 Any contraindication to the administration of G-CSF for mobilization. 4.5.3 Serious medical or psychological illness. 4.5.4 Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers. 4.5.5 HIV seropositivity. 4.5.6 The donor is pregnant, has a positive serum ßhCG or is lactating.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Fludarabine, TBI, Cyclosporine, MMF
Fludarabine 30 mg/m2/day x 3, day -4 to day -2 TBI 200 cGy x 1, day 0 For related donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For related donors: mycophenolate mofetil (MMF) 15 mg/kg p.o. q 12 hours, day 0 to day +27, then stop For unrelated donors: cyclosporine (CSP) 5 mg/kg p.o. bid, day -3 to day +56, then taper by 20% every 5 days to be completed by day +81 For unrelated donors: mycophenolate mofetil (MMF) 15 mg/kg tid day +0 to day +29, 15 mg/kg bid day +30 to day +149, and then taper by 25% per week from day +150 to day +180. Discontinue by day +181.