Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance

NCT02421575 | Terminated Early Phase 1

• 4 other identifiers: 121102NCI-2014-022160220110278P30CA072720
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with prostate cancer who are undergoing surgery or active surveillance. Autophagy is a process in which cells break down some parts of themselves to stay alive during times of stress, such as starvation. This may allow cancer cells to survive damage from chemotherapy. Hydroxychloroquine may block this process from happening.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in markers of autophagy in prostate tumor (Group I)

  Baseline to 14 days (time of surgery)

• Levels of markers of autophagy in prostate tumor (Group II)

  Up to 1 year

Secondary Outcomes (5)

• Distribution of autophagic activity in prostate cancer tissue

  Up to 1 year

• Autophagic activity, assessed by beclin-1 levels

  Up to 1 year

• Levels of markers of apoptosis in tumor tissue

  Up to 1 year

• Clinical activity, as assessed by PSA levels

  Up to 1 year

• Number of CTCs in blood samples

  Up to 1 year

Study Arms (3)

Group I, Arm I (lower dose hydroxychloroquine)

EXPERIMENTAL

Patients receive hydroxychloroquine PO QD for 14 days and then undergo prostatectomy.

Drug: Hydroxychloroquine; Other: Laboratory Biomarker Analysis

Group I, Arm II (higher dose hydroxychloroquine)

EXPERIMENTAL

Patients receive hydroxychloroquine PO TID for 14 days and then undergo prostatectomy.

Drug: Hydroxychloroquine; Other: Laboratory Biomarker Analysis

Group II (mid-dose hydroxychloroquine)

EXPERIMENTAL

Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.

Drug: Hydroxychloroquine; Other: Laboratory Biomarker Analysis

Interventions

Hydroxychloroquine DRUG

Given PO

Also known as: HCQ

Group I, Arm I (lower dose hydroxychloroquine); Group I, Arm II (higher dose hydroxychloroquine); Group II (mid-dose hydroxychloroquine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I, Arm I (lower dose hydroxychloroquine); Group I, Arm II (higher dose hydroxychloroquine); Group II (mid-dose hydroxychloroquine)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Have abnormal digital rectal examination, or abnormal prostate specific antigen (\> 4.0 ng/ml), or obstructing prostate, or biopsy proven prostate cancer
• Scheduled for prostate surgery, i.e. transurethral resection of the prostate (TURP) or prostatectomy
• Planned to be treated by active surveillance

You may not qualify if:

• Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
• Patients with psoriasis
• Patients receiving any disease-modifying anti-rheumatic drug (DMARD)
• Active clinically significant infection requiring antibiotics
• Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine
• Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone
• Patients must not have prior visual field changes from prior 4-aminoquinoline compound use
• Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria
• History of hypersensitivity to 4-aminoquinoline compound

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eric Singer, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: April 20, 2015
• Study Start: July 1, 2012
• Primary Completion: February 26, 2016
• Study Completion: February 26, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

US (1)