A Trial of FANG™ Vaccine for Participants With Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Stage III, Stage IV, epithelial ovarian cancer, ovarian cancer, Adjuvant bi-shRNAfurin and GMCSF, immunotherapy, Vigil, FANG, Autologous Tumor Cell Vaccine
Eligibility Criteria
Tissue Procurement Inclusion Criteria:
- Presumptive Stage III/IV papillary serous or endometrioid ovarian cancer.
Per Amendment #8, treatment naïve, high risk ovarian cancer will no longer be stratified, but the following information will be collected:
- Stage IV or suboptimal (>1 cm residual) Stage III disease versus Stage III patients with optimal (≤1 cm residual) disease,
- CA-125 ≤10 U/ml versus CA-125 greater than 10 but less than or equal to 20 U/ml
- IP chemotherapy versus IV chemotherapy
- Availability of "golf-ball" size 10-30 grams tissue at time of primary surgical debulking.
- ECOG performance status (PS) 0-2 prior to tumor debulking laparotomy.
- Ability to understand and the willingness to sign a written informed consent document for tissue harvest.
INCLUSION CRITERIA:
- Histologically confirmed Stage III/IV papillary serous or endometrioid ovarian cancer.
Clinically defined CR (no cancer related symptoms, normal physical examination and CT scan abdomen/pelvis and CXR, and CA-125 ≤20 U/ml) following completion of primary surgical debulking. Patients enrolled must complete at least 5 but no more than 6 cycles platinum/taxane adjuvant or interval debulking + chemotherapy (or chemotherapy as per recommendations of NCCN guidelines, category 1 (IP chemotherapy included)).
(Patients who complete surgery/chemotherapy with a CA-125 >20 U/mL pre-registration have the option of being followed up to 2 months if serial CA-125 values continue to decrease at a rate of CA-125 decrease of 50% per month.)
- Successful manufacturing of 4 vials of Vigil™ vaccine.
- Recovered from all clinically relevant toxicities related to prior protocol specific therapies (including neuropathy to ≤Grade 2).
- ECOG performance status (PS) 0-1.
Normal organ and marrow function as defined below:
Absolute granulocyte count ≥ 1,500/mm3 Absolute lymphocyte count ≥ 200/mm3 Platelets ≥ 75,000/mm3 Total bilirubin ≤ 2 mg/dL AST(SGOT)/ALT(SGPT) ≤ 2x institutional upper limit of normal Creatinine < 1.5 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 document.
EXCLUSION CRITERIA:
- Surgery involving general anesthesia, radiotherapy, or immunotherapy within 4 weeks prior to randomization. Chemotherapy within 3 weeks prior to Vigil™ vaccine administration. Steroid therapy within 1 week prior to vaccine administration.
- Patient must not have received any other investigational agents within 4 weeks vaccine administration.
- 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.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, 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.
Sites / Locations
- Florida Cancer Specialists
- Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
- Hackensack University Medical Center
- Mary Crowley Cancer Research Centers
- Texas Oncology - Sammons Cancer Center
- Texas Oncology - Fort Worth
- Cancer Care Northwest
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group A (Vigil™)
Group B (Observational - Standard of Care)
Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.
Participants received standard of care without maintenance therapy.