Phase 2
N=1
Salvage Ovarian FANG™ Vaccine + Carboplatinum
Stage III Ovarian Cancer · Stage IV Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01867086 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Time to Progression (TTP)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vigil™ Vaccine (Biological); Carboplatinum (Drug); Carboplatinum and Taxol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gradalis, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
— | — |
| PRIMARY Response Rate |
— | — |
| SECONDARY Immune Analysis in Blood |
1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01867086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.