Tetrathiomolybdate in Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase II Trail of Tetrathiomolybdate in Patients With Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150995
• Other study ID #: UMCC 9962
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: January 20, 2015
• Start date: May 2001
• Est. completion date: April 2006

Study information

• Verified date: January 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 the body but becomes uncontrolled in cancerous cells. Tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. Realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with Tetrathiomolybdate for different types of cancers. This clinical trial will evaluate the effectiveness of Tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2006
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Tetrathiomolybdate

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No