Salvage Ovarian FANG Vaccine + Bevacizumab
This study is currently recruiting participants.
Verified April 2013 by Gradalis, Inc.
Information provided by (Responsible Party):
First received: March 1, 2012
Last updated: April 5, 2013
Last verified: April 2013
This is a Phase II study of FANG™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had FANG™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive FANG™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.
Stage IIIC Ovarian Cancer
Biological: FANG™ Vaccine
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Biological: FANG™ Vaccine
Patients meeting eligibility criteria will receive FANG™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks.
Other Name: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Other Name: VEGF
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed papillary serous or endometroid ovarian cancer.
- Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CL-PTL 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 5 vials of FANG™ vaccine.
- Recovered from all clinically relevant toxicities related to prior therapies.
- ECOG PS 0-2 prior to FANG™ 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
- 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.
- 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 ≤ 0.125 mg/kg prednisone per day (maximum 10 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551745
|Mary Crowley Cancer Research Centers
|Dallas, Texas, United States, 75230 |
|Principal Investigator: Minal Barve, MD |
||Minal Barve, MD
Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I Trial of "bi-shRNAi(furin)/GMCSF DNA/Autologous Tumor Cell" Vaccine (FANG) in Advanced Cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2012
||April 5, 2013
||United States: Food and Drug Administration
Keywords provided by Gradalis, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs