Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

NCT01931046 | Completed Phase 1

• 1 other identifier: MTG-REIC-PC003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.

Conditions

Localized Prostate Cancer

Keywords

prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  To define the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) for intratumoral injection (IT) of Ad5-SGE-REIC/Dkk-3 viral vector.

  Up to 24 weeks

Secondary Outcomes (2)

• Effectiveness of Ad5-SGE-REIC/Dkk-3

  Up to 78 weeks

• Rate and intensity of adverse reactions after treatment with Ad5-SGE-REIC/Dkk-3

  Up to 54 weeks

Study Arms (2)

Part 1

EXPERIMENTAL

Treatment at one of three dose levels of Ad5-SGE-REIC/Dkk-3 in a sequential dose-escalating design with 4 cycles of therapy at each dose level permitted.

Drug: Ad5-SGE-REIC/Dkk3

Part 2

EXPERIMENTAL

Treatment with Ad5-SGE-REIC/Dkk-3 every 6-weeks for up to 4 cycles of therapy and may continue therapy if they have stable disease or are responding.

Drug: Ad5-SGE-REIC/Dkk3

Interventions

Ad5-SGE-REIC/Dkk3 DRUG

Ad5-SGE-REIC/Dkk-3, was designed to increase intracellular production REIC protein. The adenovirus vector is a transport mechanism to infuse the REIC protein into the cell providing a temporary transfusion of protein that induces apoptosis in target cancer cells, but does not appear to have a significant effect on normal tissues.

Part 1; Part 2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included:
• Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
• Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
• At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
• At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
• Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
• Life expectancy of at least 5 years.
• Subjects should have adequate bone marrow function defined as an absolute peripheral granulocyte count ≥ 1,500 and platelet count of ≥ 100,000, adequate hepatic function with a bilirubin ≤ 1.5 mg/dl and serum glutamic-pyruvic transaminase (SGPT) \< 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl
• Subjects must have a coagulation profile (prothrombin time \[PT\], partial thromboplastin time \[PTT\]) not more than 2-times the upper limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants within 5-days of the Ad5-SGE-REIC/Dkk-3 injections is limited to local use only (for control of central line patency).
• Subject is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) for 8-weeks after treatment with Ad5-SGE-REIC/Dkk-3.
• Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded:
• Prior primary radiation treatment to the prostate.
• Severe bladder outlet obstructive disorder (AUA \>25) or urinary track retention.
• Chemotherapy, immunotherapy or other investigational study drug within the past 4 weeks.
• Unable to tolerate TRUS.
• Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
• Subjects who are HIV positive or have active hepatitis B or C infections are not eligible.
• Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids continuously for \> 4 months \[\> 5 mg hydrocortisone/day\] are ineligible.
• As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.

Sponsors & Collaborators

• Momotaro-Gene Inc.: lead
• The Pacific Link Consulting Co: collaborator

Study Sites (3)

UCSD Moores Cancer Center

San Diego, California, 92093, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher J Kane, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Brian J Miles, MD, FACS

  Baylor College of Medicine and Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: July 6, 2018
• Study Completion: March 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

US (3)