Salvage Ovarian FANG Vaccine + Bevacizumab
Verified September 2013 by Gradalis, Inc.
Information provided by (Responsible Party):
First received: March 1, 2012
Last updated: September 9, 2013
Last verified: September 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 III Ovarian Cancer
Stage IV 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 2015 (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:
- 1. 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 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
- 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.
- 1. 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551745
|Mary Crowley Cancer Research Centers
|Dallas, Texas, United States, 75230 |
|Contact: Referral Office 972-566-3000 email@example.com |
|Principal Investigator: Minal Barve, MD |
||Minal Barve, MD
||Mary Crowley Cancer Research Centers
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
||September 9, 2013
||United States: Food and Drug Administration
Keywords provided by Gradalis, Inc.:
Papillary Serous Ovarian Cancer
Endometrioid Ovarian Cancer
Epithelial Ovarian Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs