Overview

This trial is active, not recruiting.

Conditions stage iii ovarian cancer, stage iv ovarian cancer
Treatments vigil™ vaccine, bevacizumab
Phase phase 2
Target VEGF
Sponsor Gradalis, Inc.
Start date March 2012
End date October 2017
Trial size 5 participants
Trial identifier NCT01551745, CL-PTL 112

Summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 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 will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
vigil™ vaccine bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
bevacizumab VEGF
Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Primary Outcomes

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

Secondary Outcomes

Measure
Time to Progression
time frame: Participants will be followed up to 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 patients with vaccine prepared for CLPTL 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 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
    • INR < 1.5
  • Baseline blood pressure must be under 140/90
  • 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. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week 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 ≤ 0.25 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 active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
  • History of Stroke/Transient Ischemic Attack
  • Use of bleeding diathesis
  • Use of anti-coagulants
  • 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.

Additional Information

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
Principal investigator Minal Barve, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Gradalis, Inc..