VB-111+Paclitaxel for Recurrent Mullerian Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer, GYN: Endometrial/Uterine Cancer
NCT ID: NCT01801215 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-418


This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved VB-111, or the combination of VB-111 with paclitaxel for use in patients, including people with your type of cancer. VB-111 is designed to kill cancer cells in the body by "cutting off" the blood flow to cancer cells and/or tumors. The process of "cutting off" the blood flow to cancer cells and/or tumors is known as anti-angiogenesis and has been shown to help prevent tumor growth. VB-111 is both a vascular disrupting (blocking blood vessels) and anti-angiogenic (preventing new blood vessel growth) agent. It is different to normal chemotherapy as it is made from an adenovirus (Cold virus) carrying a human gene that kills cell lining blood vessels (Endothelial cells). This virus is a 'non-replicating' virus, meaning it cannot grow in the body. Paclitaxel is a chemotherapy drug which is FDA approved for use in your type of cancer. In this research study, we are looking for the highest dose of VB-111 that can be given safely in combination with paclitaxel to patients with platinum-resistant ovarian cancer.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Richard Penson, MD, Massachusetts General Hospital

Site-responsible Investigators:
Suzanne Berlin, DO, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - Up to 3 previous lines of chemotherapy for metastatic disease are allowed - Must have had prior platinum or platinum based therapy - Platinum resistant or refractory disease - Measurable or evaluable disease - Must have recovered from acute toxicity from prior treatment Exclusion Criteria: - Prior GI perforation or GI obstruction or involvement of the bowel on imaging - Active untreated psychiatric disease or neurologic symptoms requiring treatment - Known hypersensitivity to Cremophor EL - Evidence of uncontrolled bacterial, viral or fungal infections - Receiving other investigational therapy for the past 30 days before dosing - More than 3 prior lines of chemotherapy for recurrent cancer - Other active malignancy - Inadequately controlled hypertension - NYHA Grade II or greater congestive heart failure - History of myocardial infarction or transient ischemic attack within 6 months - Known CNS disease, except for treated brain metastasis - Significant vascular disease - History of hemoptysis within 1 month - Evidence of bleeding diathesis or significant coagulopathy - Major surgical procedure within 28 days - Ongoing requirement for an immunosuppressive treatment - Pregnant or breastfeeding
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