Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
RATIONALE: Hydroxychloroquine may stop the growth of tumor cells by blocking some of the cellular functions needed for cells to survive.
PURPOSE: This phase II trial is studying how well hydroxychloroquine works in treating patients with rising prostate-specific antigen (PSA) levels after local therapy for prostate cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NJ 1808: Autophagic Cell Death in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer|
- Prostate-specific antigen (PSA) response [ Time Frame: Treatment start date to date of best PSA response ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Hydroxychloroquine will be taken at a dose of 200 mg twice per day in the first 27 patients. Thereafter, the dose of hydroxychloroquine will then be increased to 600mg per day 200mg three times per day).
- To determine the effect on biological activity, as assessed by prostate-specific antigen (PSA) response, of hydroxychloroquine in patients with hormone-dependent PSA progression after local therapy for prostate cancer.
- To determine the feasibility and safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral hydroxychloroquine daily for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
|United States, New Jersey|
|Cancer Institute of New Jersey at Hamilton||Recruiting|
|Hamilton, New Jersey, United States, 08690|
|Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Recruiting|
|Morristown, New Jersey, United States, 07962|
|Contact: Contact Person 973-971-6100|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675|
|Summit, New Jersey, United States, 07901|
|Contact: Contact Person 908-522-2000|
|Cooper University Hospital Cancer Institute||Recruiting|
|Voorhees, New Jersey, United States, 08043|
|Contact: Contact Person 800-826-6737|
|Principal Investigator:||Mark Stein, MD||Cancer Institute of New Jersey|