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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00726596 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: hydroxychloroquine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | NJ 1808: Autophagic Cell Death in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer |
Estimated Enrollment: | 27 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Must have undergone local treatment via prostatectomy or radiotherapy and have shown PSA progression
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
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 |
Principal Investigator: | Mark Stein, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000600326, CINJ-080803 |
Study First Received: | July 31, 2008 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00726596 |
Health Authority: | Unspecified |
recurrent prostate cancer stage IV prostate cancer |
Death Prostatic Diseases Genital Neoplasms, Male Hydroxychloroquine Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Recurrence |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Neoplasms Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors Antirheumatic Agents Pharmacologic Actions |