Official Title: “NJ 1808: Autophagic Cell Death in Patients With Hormone-Dependent Prostate-Specific Antigen Progression 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 Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: July 2011

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.

Intervention(s) in this Clinical Trial

• Drug: hydroxychloroquine

Primary Measures

• Prostate-specific antigen (PSA) response
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer Institute of New Jersey

Overall Clinical Trial Officials and Contacts

Mark Stein, MD Principal Investigator Cancer Institute of New Jersey  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00726596

Study ID Number: CDR0000600326

ClinicalTrials.gov Identifier: NCT00726596

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database