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Status:

WITHDRAWN

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

Lead Sponsor:

OHSU Knight Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18-75 years

Phase:

PHASE2

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 sy...

Detailed Description

OBJECTIVES: * Determine the treatment-related mortality in patients with hormone-refractory, progressive metastatic prostate cancer treated with nonmyeloablative conditioning comprising fludarabine a...

Eligibility Criteria

Inclusion

  • 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
  • 1 Patient Inclusion Criteria:
  • 1.1 Males aged 18-75.
  • 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).
  • 1.3 Progressive disease despite hormonal management (including antiandrogen withdrawal, 6 weeks for bicalutamide, 4 weeks for flutamide or nilutamide)
  • 1.4 PSA \> 5 ng/mL
  • 1.5 Serum testosterone level \< 50 ng/mL
  • 1.6 Prior treatment with a docetaxel-based regimen.
  • 1.7 Performance status: Karnofsky Performance Scale (KPS) 70-100%. (Appendix III).
  • 1.8 Signed informed patient consent.
  • 2 Patient Exclusion criteria:
  • 2.1 Expected survival less than 6 months
  • 2.2 Active central nervous system involvement or spinal instability
  • 2.3 Organ dysfunction:
  • 2.3.1 Cardiac: Ejection fraction \<35% or symptomatic congestive heart failure.
  • 2.3.2 Pulmonary: DLCO \<40% of predicted or either TLC or FEV1 \< 30% predicted.
  • 2.3.3 Liver dysfunction: serum total bilirubin \>2x upper limit of normal (ULN) or either ALT or AST \>4x ULN
  • 2.3.4 Renal dysfunction: creatinine clearance \< 50 ml/min
  • 2.4 HIV seropositivity
  • 2 Related Donor Inclusion criteria:
  • 3.1 Age 18-75
  • 3.2 Related to the patient and genotypically or phenotypically HLA-identical. (Appendix IV)
  • 3.3 Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow donors are not eligible.
  • 3 Unrelated Donor Inclusion criteria:
  • 4.1 Age 18-75.
  • 4.2 Unrelated donors who are prospectively:
  • 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.
  • 4.3 Able to give consent to peripheral blood stem cell mobilization with G-CSF and apheresis collection. Bone marrow unrelated donors are not eligible.
  • 4 Related and Unrelated Donor Exclusion criteria:
  • 5.1 Identical twin.
  • 5.2 Any contraindication to the administration of G-CSF for mobilization.
  • 5.3 Serious medical or psychological illness.
  • 5.4 Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers.
  • 5.5 HIV seropositivity.
  • 5.6 The donor is pregnant, has a positive serum ßhCG or is lactating.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2008

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00242931

    Start Date

    January 1 2005

    End Date

    March 1 2008

    Last Update

    June 1 2012

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