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Trial record 27 of 278 for:    prostate cancer AND localized | ( Map: United States )

Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931046
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
The Pacific Link Consulting Co
Information provided by (Responsible Party):
Momotaro-Gene Inc.

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.

Condition or disease Intervention/treatment Phase
Localized Prostate Cancer Drug: Ad5-SGE-REIC/Dkk3 Phase 1 Phase 2

Detailed Description:

This is a phase 1/2a clinical trial in subjects who are diagnosed with prostate cancer to evaluate the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of localized prostate cancer.

Subjects enrolled will be diagnosed with localized prostate cancer (clinical stage T1/T2) having a Gleason score of 6 to 7 (3+4 or 4+3). Subjects will receive up to four (4) transrectal ultrasound (TRUS)-guided IT treatments with Ad5-SGE-REIC/Dkk-3 into the prostate approximately 6-weeks apart. Each treatment cycle will be performed using a minimum of three track injections through the prostrate using a total of 3 mL volume. Approximately 2 mL of the total volume will be injected into the most dense areas of cancer based on biopsy and MRI mapping (fusion biopsy) and 1 mL total volume will be injected into the opposite lobe of the prostate or other areas to ensure complete saturation of the prostate over multiple injections.

Subjects who, in the opinion of the investigator, are progressing at any time after the second injection of Ad5-SGE-REIC/Dkk-3 may be discontinued and will be treated according to standard medical practice.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: A Phase 1 / 2a Study of In-situ REIC/Dkk-3 Therapy in Patients With Localized Prostate Cancer (MTG-REIC-PC003)
Study Start Date : October 2013
Actual Primary Completion Date : July 6, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Part 1
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
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.

Experimental: Part 2
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
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.




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: Up to 24 weeks ]
    To define the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) for intratumoral injection (IT) of Ad5-SGE-REIC/Dkk-3 viral vector.


Secondary Outcome Measures :
  1. Effectiveness of Ad5-SGE-REIC/Dkk-3 [ Time Frame: Up to 78 weeks ]
    To assess the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of prostate cancer as evaluated by biomarkers, transrectal ultrasound (TRUS), biopsy and MRI.

  2. Rate and intensity of adverse reactions after treatment with Ad5-SGE-REIC/Dkk-3 [ Time Frame: Up to 54 weeks ]
    To assess the rate of adverse events and grade of adverse events after in-situ therapy with Ad5-SGE-REIC/Dkk-3 protein in prostate cancer subjects.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Key Inclusion Criteria:

Subjects must meet all of the following criteria to be included:

  1. Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
  2. Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
  3. At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
  4. At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
  5. Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
  6. Life expectancy of at least 5 years.
  7. 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
  8. 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).
  9. 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.
  10. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

Key Exclusion Criteria

Subjects meeting any of the following criteria will be excluded:

  1. Prior primary radiation treatment to the prostate.
  2. Severe bladder outlet obstructive disorder (AUA >25) or urinary track retention.
  3. Chemotherapy, immunotherapy or other investigational study drug within the past 4 weeks.
  4. Unable to tolerate TRUS.
  5. 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.
  6. Subjects who are HIV positive or have active hepatitis B or C infections are not eligible.
  7. 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.
  8. As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931046


Locations
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United States, California
UCSD Moores Cancer Center
San Diego, California, United States, 92093
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
Momotaro-Gene Inc.
The Pacific Link Consulting Co
Investigators
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Principal Investigator: Christopher J Kane, MD University of California, San Diego
Principal Investigator: Brian J Miles, MD, FACS Baylor College of Medicine and Methodist Hospital

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Responsible Party: Momotaro-Gene Inc.
ClinicalTrials.gov Identifier: NCT01931046     History of Changes
Other Study ID Numbers: MTG-REIC-PC003
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Keywords provided by Momotaro-Gene Inc.:
prostate cancer
adenocarcinoma of the prostate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases