Overview

This trial is active, not recruiting.

Conditions stage iii ovarian cancer, stage iv ovarian cancer
Treatments vigil™ vaccine, carboplatinum, carboplatinum and taxol
Phase phase 2
Sponsor Gradalis, Inc.
Start date June 2013
End date July 2016
Trial size 1 participant
Trial identifier NCT01867086, CL-PTL 110

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
vigil™ vaccine bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
carboplatinum
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 three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
carboplatinum and taxol
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 three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.

Primary Outcomes

Measure
Response Rate
time frame: Participants will be followed up to 24 months

Secondary Outcomes

Measure
Time to Progression
time frame: Patients will be followed for 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Gradalis, Inc..