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Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00726596
  Purpose

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

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Hydroxychloroquine Hydroxychloroquine sulfate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: May 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Stage D0 (stage IV) disease (i.e., tumor limited to the prostate with rising prostate-specific antigen [PSA] value after definitive local therapy)
    • No metastases (confirmed by bone scan and CT scan of abdomen/pelvis)
  • Must have undergone local treatment via prostatectomy or radiotherapy and have shown PSA progression

    • After surgery, PSA values > 0.2 ng/mL, determined by two measurements at least 1 month apart and at least 6 months after prostatectomy
    • After radiotherapy, PSA values ≥ 2.0 ng/mL greater than the nadir achieved after radiotherapy, determined by two measurements at 1 month apart and at least 6 months after the radiotherapy
    • The first two PSA values, along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • WBC > 3,500/mm³
  • ANC > 1,500/mm³
  • Hemoglobin > 10 g/dL
  • Platelet count > 100,000/mm³
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min
  • Total bilirubin normal
  • ALT and AST < 2.5 times upper limit of normal
  • No evidence of retinopathy by ophthalmic exam within the past 12 months
  • No serious concurrent systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
  • No psoriasis
  • No active clinically significant infection requiring antibiotics
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • No retinal or visual field changes from prior 4-aminoquinoline compound
  • No history of hypersensitivity to 4-aminoquinoline compound
  • No other malignancy within the past 5 years except in situ carcinoma (e.g., adequately treated nonmelanoma skin cancer)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 months since prior hormone-ablative treatment (neoadjuvant therapy allowed)
  • No concurrent treatment for rheumatoid arthritis or systemic lupus erythematosus
  • No concurrent disease-modifying anti-rheumatic drug
  • No other concurrent commercially available medications that may either stimulate or inhibit autophagy (e.g., calcitriol and hydroxychloroquine)
  • No concurrent medications that may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone
  • No other concurrent hydroxychloroquine for treatment or prophylaxis of malaria
  • No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or other experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726596

Locations
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        
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: Mark Stein, MD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000600326, CINJ-080803
Study First Received: July 31, 2008
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00726596  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Death
Prostatic Diseases
Genital Neoplasms, Male
Hydroxychloroquine
Disease Progression
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009