GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02759588|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Carcinomatosis Fallopian Tube Cancer||Biological: GL-ONC1||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b/2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer (VIRO-15)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||March 2019|
A genetically-engineered oncolytic vaccinia virus administered via intraperitoneal infusion as multiple doses.
- Incidence of Treatment-emergent Adverse Events [Safety and Tolerability] (Phase 1b) [ Time Frame: Change from baseline during Treatment and for 30 days following last dose. ]Determine safety and tolerability of administering multiple doses of GL-ONC1 via intraperitoneal catheter by the evaluation of the number of participants with treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
- Determine Progression-free Survival following Treatment (Phase 2) [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. ]To assess progression-free survival (PFS) from time of registration until disease
- Evaluation of Tumor Response to Treatment [ Time Frame: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. ]Evaluate participant's best overall response to treatment with therapeutic intent assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (i.e., complete response, partial response, stable disease, or progressive disease).
- Evaluation of Tumor Response to Treatment with Oncolytic Immunotherapy [ Time Frame: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months. ]Evaluate participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease).
- Tumor Marker Cancer Antigen-125 Response to Treatment with Oncolytic Immunotherapy [ Time Frame: Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months. ]Cancer Antigen (CA)-125 response to treatment according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment.
- Determine Progression-free Survival following Treatment (Phase 1b) [ Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months. ]To assess progression-free survival (PFS) from time of registration until disease progression or death in participant population.
- Overall Survival [ Time Frame: By medical chart review until death or 3 years from the date of last treatment which ever comes first. ]To determine overall survival (OS) with the treatment regimen in the participant population.
- Clinical Benefit Rate [ Time Frame: Approximately 24 months ]Defined as the percentage of patients who have achieved CR + PR + SD greater than or equal to 24 weeks.
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): NCT02759588
|United States, California|
|Gynecologic Oncology Associates||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Katrina Lopez, CCRC 949-642-5165 email@example.com|
|Principal Investigator: Alberto Mendivil, MD, FACOG, FACS|
|United States, Florida|
|Florida Hospital Cancer Institute||Recruiting|
|Orlando, Florida, United States, 32804|
|Contact: Susan Coakley 407-303-2090 firstname.lastname@example.org|
|Principal Investigator: Robert W. Holloway, MD, FACOG, FACS|