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Trial record 1 of 1 for:    NCT02759588
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GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02759588
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent ovarian cancer and peritoneal carcinomatosis.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Carcinomatosis Fallopian Tube Cancer Biological: GL-ONC1 Phase 1 Phase 2

Detailed Description:
Ovarian cancer (OC) remains the most lethal gynecologic malignancy owing to late detection, intrinsic and acquired chemo-resistance and remarkable heterogeneity. There is an unmet medical need to develop new therapy modalities. In preclinical studies, GL-ONC1, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 30 different human tumors, including ovarian cancer. GL-ONC1 has been investigated in early stage clinical trials in the United States and Europe via systemic delivery as monotherapy and in combination with other therapies, and via regional delivery as monotherapy. GL-ONC1 treatment was well tolerated across different malignancies, routes of administration, and monotherapy as well as combination therapy protocols. The ability of GL-ONC1 to infect tumor tissue and kill tumor cells was demonstrated. In addition, virus-induced immune activation and favorable anti-tumor immune response have been observed. Evidences of anti-tumor efficacy and clinical benefits have also been documented.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GL-ONC1 Biological: GL-ONC1
A genetically-engineered oncolytic vaccinia virus administered via intraperitoneal infusion as multiple doses.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed, written informed consent.
  • High-grade serous (including Malignant Mixed Mullerian Tumor (MMMT) with metastasis that contains high grade epithelial carcinoma), endometrioid, or clear-cell ovarian cancer which includes: (1) platinum-resistant (recurrence or progression in < 6 months) or (2) platinum-refractory (progression while on platinum-based therapy); patient must have failed either at least 2 consecutive therapies or are not eligible for additional cytotoxic therapies.
  • Intermediate platinum-sensitive patients (recurrence of disease 6 to 12 months from last platinum compound treatment): Recurrent ovarian carcinoma with at least four prior individual treatment regimens including at least two separate platinum-based therapies with recurrence from the last platinum-based regimen less than 12 months, who are unwilling or unable to undergo additional platinum-based cytotoxic therapy.
  • Performance status ECOG is at 0 or 1, and life expectancy of 6 months
  • Has either measurable disease in the peritoneal cavity as defined by RECIST 1.1 (Phase 1b & 2) or has non-measurable disease in the peritoneal cavity (Phase 1b) and can be confirmed by laparoscopy and/or elevated CA-125. Patients who have non-measurable disease that is not identifiable by PET/PET-CT scan, but who have elevated CA-125, and/or ascites, with visible disease confirmed by laparoscopy are also eligible.
  • Able to undergo IP injection.
  • Adequate renal, hepatic, bone marrow and immune functions.
  • Baseline tumor biopsy is required.
  • Documented progressive disease status at baseline (Phase 2).

Exclusion Criteria:

  • Tumors of mucinous subtypes, or non-epithelial ovarian cancers (e.g., Brenner tumors, Sex-cord tumors).
  • Unresolved bowel obstruction.
  • Known central nervous system (CNS) metastasis.
  • Known seropositivity for HIV or active hepatitis infection.
  • History of thromboembolic event within the last 3 months.
  • Pregnant or breast-feeding women.
  • Smallpox vaccination within 1 year of study treatment.
  • Clinically significant cardiac disease.
  • Received prior gene therapy or therapy with cytolytic virus of any type.
  • Receiving concurrent antiviral agent active against vaccinia virus.
  • Have known allergy to ovalbumin or other egg products.
  • Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or unhealed skin wounds or ulcers) as assessed by the Investigator.
  • Symptomatic malignant ascites and non-manageable pleural effusion.
Contacts and Locations

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): NCT02759588


Locations
United States, California
Gynecologic Oncology Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Katrina Lopez, CCRC    949-642-5165    katrinal@gynoncology.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    susan.coakley@flhosp.org   
Principal Investigator: Robert W. Holloway, MD, FACOG, FACS         
Sponsors and Collaborators
Genelux Corporation
More Information

Additional Information:
Responsible Party: Genelux Corporation
ClinicalTrials.gov Identifier: NCT02759588     History of Changes
Other Study ID Numbers: GL-ONC1-015
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Genelux Corporation:
GL-ONC1
oncolytic virus
virotherapy
Viral therapy
immunotherapy
immune therapy
vaccinia
vaccinia virus
Genelux
ovarian cancer
platinum resistant
platinum refractory
peritoneal carcinomatosis
fallopian cancer
cancer
abdominal cancer
imaging
carcinoma
DNA virus
neoplasms
neoplasms by histological type
neoplasms, Glandular and Epithelial
Poxviridae infections
Virus diseases
recurrent ovarian cancer
intermediate platinum-sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type