Tetrathiomolybdate in Hormone Refractory Prostate Cancer

NCT00150995 | Completed Phase 2 DMC

• 1 other identifier: UMCC 9962
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  To determine the time to progression of prostate cancer in patients with androgen-independent prostate cancer treated with tetrathiomolybdate. Disease progression is defined as at least a 20% increase in the sum of the longest diameter of the target lesions. For disease evaluable only by bone scan, the appearance of new lesions was considered evidence of progression. The development of pain in an existing lesion requiring institution of palliative radiotherapy or prescription narcotics was also considered evidence of progression.

  12 weeks

Study Arms (1)

Tetrathiomolybdate

EXPERIMENTAL

Patients will be started on a dose of 60mg Tetrathiomolybdate at bedtime and 40mg 3 times per day.

Drug: Tetrathiomolybdate

Interventions

Tetrathiomolybdate DRUG

Tetrathiomolybdate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tetrathiomolybdate

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

• David C. Smith, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: September 6, 2005
• First Posted: September 8, 2005
• Study Start: May 1, 2001
• Primary Completion: October 1, 2003
• Study Completion: April 1, 2006
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (1)