Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| 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 | |
| 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