Status:
COMPLETED
Tetrathiomolybdate in Hormone Refractory Prostate Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.
Detailed Description
Tetrathiomolybdate or TM, a drug developed for Wilson's Disease, removes copper from the bloodstream. Copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in th...
Eligibility Criteria
Inclusion
- Inclusion:
- Patients must have histologic diagnosis of adenocarcinoma of the prostate with progression following hormonal therapy and antiandrogen withdrawal.
- Patients must have minimal disease (defined as bone metastasis or visceral disease with no impairment of organ function or pain severe enough to require narcotics for control).
- Adequate bone marrow and renal function
- ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (a measure of general well being where 1 represents asymptomatic and 5 represents death)
- Life expectancy of at least 16 weeks
- Must have completed radiation more than 4 weeks prior to registration and must have a rising PSA (Prostate Specific Antigen) and lesion outside of the radiation field
- Exclusion:
- Patients with an elevated PSA as the only evidence of disease
- Clinical evidence of spinal cord compression
- History of prior malignancy within the past 5 years (with the exception of in situ carcinoma of any site or nonmelanoma skin cancer)
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00150995
Start Date
May 1 2001
End Date
April 1 2006
Last Update
January 21 2015
Active Locations (1)
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1
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109