Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI	CINJ-080803 080803, NCT00726596

Objectives

Primary

1. 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

1. To determine the feasibility and safety of this regimen in these patients.

Entry 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)

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

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)

Expected Enrollment

Outcomes

Prostate-specific antigen (PSA) response

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Mark Stein, MD, Principal investigator		Ph: 732-235-6777

U.S.A.
New Jersey
	Hamilton
	Cancer Institute of New Jersey at Hamilton
		Clinical Trials Office - Cancer Institute of New Jersey at Hamilton	Ph:  609-631-6946
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Contact Person	Ph:  973-971-6100 800-247-9580
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Summit
	Overlook Hospital
		Contact Person	Ph:  908-522-2000

Registry Information
Official Title		NJ 1808: Autophagic Cell Death in Patients with Hormone-Dependent Prostate-Specific Antigen Progression after Local Therapy for Prostate Cancer
Trial Start Date		2008-08-12
Trial Completion Date		2011-07-07 (estimated)
Registered in ClinicalTrials.gov		NCT00726596
Date Submitted to PDQ		2008-07-14
Information Last Verified		2009-07-17
NCI Grant/Contract Number		CA72720

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