Flu/TBI in Treating Patients Not Responding to Previous Hormone Therapy

NCT00242931 | Withdrawn Phase 2 DMC

• 3 other identifiers: CDR0000447211OHSU-SOL-04109-LOHSU-373
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 progressive metastatic prostate cancer that has not responded to previous hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Treatment-related mortality as measured by Kaplan-Meier at 5 years following transplant

Secondary Outcomes (5)

• Safety by CTCAE v 3.0 at 100 days following transplant

• Response rate by RECIST criteria at 5 years following transplant

• Time to progression by Kaplan-Meier at 5 years following transplant

• Overall survival by Kaplan-Meier at 5 years following transplant

• Response as measured by a 50% reduction in the prostate-specific antigen at 5 years following transplant

Study Arms (1)

Fludarabine, TBI, Cyclosporine, MMF

EXPERIMENTAL

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.

Other: Nonmyeloablative stem cell conditioning regimen

Interventions

Nonmyeloablative stem cell conditioning regimen OTHER

Conditioning: Fludarabine 30 mg/m2/day x 3, day -4 to day -2 TBI 200 cGy x 1, day 0 Hematopoeitic Stem Cell Transplantation: Infusion of peripheral blood stem cells, day 0 Immunosuppression: 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.

Also known as: Mini Transplant

Fludarabine, TBI, Cyclosporine, MMF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18-75.
• 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).
• Progressive disease despite hormonal management (including antiandrogen withdrawal, 6 weeks for bicalutamide, 4 weeks for flutamide or nilutamide)
• PSA \> 5 ng/mL
• Serum testosterone level \< 50 ng/mL
• Prior treatment with a docetaxel-based regimen.
• Performance status: Karnofsky Performance Scale (KPS) 70-100%. (Appendix III).
• Signed informed patient consent.

You may not qualify if:

• Expected survival less than 6 months
• Active central nervous system involvement or spinal instability
• Organ dysfunction:
• Cardiac: Ejection fraction \<35% or symptomatic congestive heart failure.
• Pulmonary: DLCO \<40% of predicted or either TLC or FEV1 \< 30% predicted.
• Liver dysfunction: serum total bilirubin \>2x upper limit of normal (ULN) or either ALT or AST \>4x ULN
• Renal dysfunction: creatinine clearance \< 50 ml/min
• HIV seropositivity
• Age 18-75
• Related to the patient and genotypically or phenotypically HLA-identical. (Appendix IV)
• Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow donors are not eligible.
• Age 18-75.
• Unrelated donors who are prospectively:
• 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.
• Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow unrelated donors are not eligible.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Brandon M. Hayes-Lattin, MD

  Oregon Health and Science University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 1, 2012

Record last verified: 2010-09