Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

This study is currently recruiting participants.
Verified November 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
Collaborator:
Information provided by (Responsible Party):
CINJRegulatory, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00726596
First received: July 31, 2008
Last updated: November 9, 2012
Last verified: November 2012
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) response [ Time Frame: Treatment start date to date of best PSA response ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
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)
Arms Assigned Interventions
Experimental: Hydroxychloroquine
Hydroxychloroquine
Drug: hydroxychloroquine
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).

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 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        
Overlook Hospital Recruiting
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        
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Mark Stein, MD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: CINJRegulatory, Mark Stein, MD - Asst professor of medicine, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00726596     History of Changes
Other Study ID Numbers: CDR0000600326, P30CA072720, CINJ-080803
Study First Received: July 31, 2008
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hydroxychloroquine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013