Salvage Ovarian FANG Vaccine + Bevacizumab
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IIIC Ovarian Cancer |
Biological: FANG™ Vaccine Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Response Rate [ Time Frame: Participants will followed up to 24 months ] [ Designated as safety issue: No ]To determine the response rate and time to progression (TTP) following bevacizumab integrated with FANG™ vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production.
- Time to Progression [ Time Frame: Participants will be followed up to 24 months ] [ Designated as safety issue: No ]To determine the response rate and time to progression (TTP) following bevacizumab integrated with FANG™ vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production.
| Estimated Enrollment: | 6 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
-
Biological: FANG™ Vaccine
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Meghan Degele | 972-566-3062 | mdegele@marycrowley.org |
| Contact: Rachel Marshall | 972-566-3061 | rmarshall@marycrowley.org |
| United States, Texas | |
| Mary Crowley Cancer Research Centers | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Principal Investigator: Minal Barve, MD | |
| Principal Investigator: | Minal Barve, MD | Principal Investigator |
More Information
Publications:
| Responsible Party: | Gradalis, Inc. |
| ClinicalTrials.gov Identifier: | NCT01551745 History of Changes |
| Other Study ID Numbers: | CL-PTL 112 |
| Study First Received: | March 1, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gradalis, Inc.:
|
ovarian cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013