Salvage Ovarian FANG™ Vaccine + Carboplatinum
This trial is active, not recruiting.
|Conditions||stage iii ovarian cancer, stage iv ovarian cancer|
|Treatments||vigil™ vaccine, carboplatinum, carboplatinum and taxol|
|Start date||June 2013|
|End date||July 2016|
|Trial size||1 participant|
|Trial identifier||NCT01867086, CL-PTL 110|
This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Participants will be followed up to 24 months
Time to Progression
time frame: Patients will be followed for 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 or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.
- Recurrent cisplatinum-sensitive 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 after a 6 month period after platinum treatment.
- 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
- 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.
- 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 peripheral neuropathy ≥2 (paclitaxel).
- 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 Chemotherapy for Patients With Recurrent Cisplatinum Sensitive Ovarian Cancer Participating in Study CL-PTL 105|
|Principal investigator||Minal Barve, MD|
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