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

NCT00242931 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-06-01

No results posted yet for this study

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

Interventions

OTHER

Nonmyeloablative stem cell conditioning regimen

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Brandon M. Hayes-Lattin, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00242931 on ClinicalTrials.gov