Florida Hospital Clinical Trial GL-ONC1-015: Phase 1b Study with GL-ONC1 Oncolytic Immunotherapy in Patients with Platinum-resistant or Refractory Ovarian Cancer
- May 19, 2016
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- New Clinical Trials Available at FHCI:
Ovarian Cancer and peritoneal carcinomatosis:
GL-ONC1-015: This is an open-label, non-randomized Phase 1b study evaluating the safety and immunotherapeutic effect of GL-ONC1, an oncolytic vaccinia virus, in women diagnosed with platinum-resistant ovarian cancer and peritoneal carcinomatosis. GL-ONC1 is administered via an intraperitoneal catheter.
- Clinical Trial Profile:
Clinical Protocol GL-ONC1-015: Phase 1b Study with GL-ONC1 Oncolytic Immunotherapy in Patients With Platinum-resistant or Refractory Ovarian Cancer: Investigator: Robert W. Holloway, MD, FACOG, FACS, Medical Director, Gynecologic Oncology Program, Florida Hospital Cancer Institute, Orlando, FL.
Ovarian cancer (OC) remains the most lethal gynecologic malignancy owing to late detection, intrinsic and acquired chemo-resistance and remarkable heterogeneity. Despite optimization of surgical and chemotherapy protocols, and initiation of clinical trials incorporating targeted therapy, only modest gains have been achieved in prolonging the survival of patients diagnosed with OC. Therefore, there is an unmet medical need to develop new therapeutic modalities.
Recently, the combination of non-platinum single agent therapies with bevacizumab have shown a significant increase of PFS from 3.4 months to 6.7 months, and an increase of survival from 13.3 months to 16.6 months in platinum-resistant ovarian cancer Bevacizumab is now FDA-approved for use with single-agent chemotherapies for platinum-resistant ovarian cancer in the United States.
Oncolytic vaccinia viral immunotherapy represents a novel approach to the treatment of cancer. Oncolytic viruses are designed to target genetic abnormalities, and thus selectively infect and replicate in cancer cells while sparing adjacent, normal cells. Experimental non-clinical data provide evidence that following entry into cancer cells, viral replication, subsequent cell lysis and further viral spread occurs selectively within the targeted cells. Oncolytic vaccinia virus may kill cancer cells by a number of mechanisms including virus replication-associated necrosis (i.e., ‘oncolysis’), induction of tumor-specific T lymphocytes, induction of bystander cell killing, and by viral induction of changes in tumor-associated vasculature.
The research hypothesis of this clinical trial is that GL-ONC1 is well tolerated and will exhibit anti-tumor activity in this disease population. The purpose of this study is to assess safety and tolerability of GL-ONC1 administered via intraperitoneal (IP) catheter as a monotherapy in patients with platinum-resistant or refractory ovarian cancer and peritoneal carcinomatosis.
Secondary objectives include investigating the response to treatment with therapeutic intent by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, by the Immune-related Response Criteria (irRC) as an exploratory endpoint, and by CA-125 according to the Gynecologic Cancer Intergroup (GCIG) CA-125 response criteria in patients with measurable disease. Patients who enter with no measurable disease will be evaluated for response by PET/PET CT scan, physical examination and CA-125 levels. Clinical benefit will be evaluated by progression-free survival (PFS) and overall survival (OS).