Salvage Ovarian FANG™ Vaccine + Bevacizumab
This trial is active, not recruiting.
|Conditions||stage iii ovarian cancer, stage iv ovarian cancer|
|Treatments||vigil™ vaccine, bevacizumab|
|Start date||March 2012|
|End date||October 2017|
|Trial size||5 participants|
|Trial identifier||NCT01551745, CL-PTL 112|
This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Participants will followed up to 24 months
Time to Progression
time frame: Participants will be followed up to 24 months
Male or female participants at least 18 years old.
- Histologically confirmed papillary serous or endometrioid ovarian cancer.
- Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CLPTL 105 but not otherwise qualifying.
- Recurrent cisplatinum resistant/refractory disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements with no intervening therapy.
- Successful manufacturing of 4 vials of Vigil™ vaccine.
- Recovered from all clinically relevant toxicities related to prior therapies.
- ECOG PS 0-2 prior to Vigil™ vaccine administration.
- Normal organ and marrow function as defined below:
- Absolute granulocyte count ≥1,500/mm3
- Absolute lymphocyte count ≥ 200/mm3
- Platelets ≥100,000/mm3
- Total bilirubin ≤1.5 x ULN
- AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
- Creatinine <1.5 mg/dL
- INR < 1.5
- Baseline blood pressure must be under 140/90
- Urine protein-to-creatinine ratio < 1.0 mg/dL.
- Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
- Ability to understand and the willingness to sign a written informed protocol specific consent.
- Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
- Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
- Patient must not have received any other investigational agents within 4 weeks prior to study entry.
- Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
- Patients with history of brain metastases.
- Patients with compromised pulmonary disease.
- Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
- Prior splenectomy.
- Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
- Kaposi's Sarcoma.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
- History of Stroke/Transient Ischemic Attack
- Use of bleeding diathesis
- Use of anti-coagulants
- Patients with clinically significant cardiovascular disease including any of the following:
- Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block.
- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
- Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
- New York Heart Association grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication.
- Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit
- History of cerebrovascular accident within the past 6 months.
- No significant traumatic injury within the past 28 days.
- Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with known HIV.
- Patients with chronic Hepatitis B and C infection.
- Patients with uncontrolled autoimmune diseases.
|Official title||Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Bevacizumab for Patients With Recurrent/Refractory Ovarian Cancer Participating in Study CL-PTL 105|
|Principal investigator||Minal Barve, MD|
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