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Salvage Ovarian FANG™ Vaccine + Bevacizumab

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ClinicalTrials.gov Identifier: NCT01551745
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

March 1, 2012
March 13, 2012
February 15, 2018
May 1, 2018
May 1, 2018
March 2012
April 2016   (Final data collection date for primary outcome measure)
  • Time to Progression [ Time Frame: 24 months ]
    Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
  • Response Rate [ Time Frame: Up to 12 months ]
    Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Response Rate [ Time Frame: Participants will followed up to 24 months ]
To determine the response rate and time to progression (TTP) following bevacizumab integrated with FANG™ vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production.
Complete list of historical versions of study NCT01551745 on ClinicalTrials.gov Archive Site
  • Number of Alive Subjects [ Time Frame: 24 months ]
    Survival status of patients after treatment will be determined.
  • Immune Analysis in Blood [ Time Frame: Up to 12 months ]
    Immune function analysis including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens will be monitored at baseline, prior to Vigil™ vaccine administrations 2, 3, and 4, and EOT.
Time to Progression [ Time Frame: Participants will be followed up to 24 months ]
To determine the response rate and time to progression (TTP) following bevacizumab integrated with FANG™ vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production.
Not Provided
Not Provided
 
Salvage Ovarian FANG™ Vaccine + Bevacizumab
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Biological: Vigil™ 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).
    Other Names:
    • bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
    • formerly known as FANG™
  • Drug: Bevacizumab
    Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
    Other Name: VEGF
Experimental: Vigil™ Vaccine
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).
Interventions:
  • Biological: Vigil™ Vaccine
  • Drug: Bevacizumab
Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
6
April 2016
April 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically confirmed papillary serous or endometrioid ovarian cancer.
  2. 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.
  3. 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.
  4. Successful manufacturing of 4 vials of Vigil™ vaccine.
  5. Recovered from all clinically relevant toxicities related to prior therapies.
  6. ECOG PS 0-2 prior to Vigil™ vaccine administration.
  7. Normal organ and marrow function as defined below:

    1. Absolute granulocyte count ≥1,500/mm3
    2. Absolute lymphocyte count ≥ 200/mm3
    3. Platelets ≥100,000/mm3
    4. Total bilirubin ≤1.5 x ULN
    5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
    6. Creatinine <1.5 mg/dL
    7. INR < 1.5
  8. Baseline blood pressure must be under 140/90
  9. Urine protein-to-creatinine ratio < 1.0 mg/dL.
  10. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  11. Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion Criteria:

  1. 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.
  2. Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
  3. Patient must not have received any other investigational agents within 4 weeks prior to study entry.
  4. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
  5. Patients with history of brain metastases.
  6. Patients with compromised pulmonary disease.
  7. 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.
  8. Prior splenectomy.
  9. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  10. Kaposi's Sarcoma.
  11. 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.
  12. History of Stroke/Transient Ischemic Attack
  13. Use of bleeding diathesis
  14. Use of anti-coagulants
  15. Patients with clinically significant cardiovascular disease including any of the following:

    1. Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block.
    2. Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
    3. Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
    4. New York Heart Association grade II or greater congestive heart failure.
    5. Serious cardiac arrhythmia requiring medication.
    6. Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit
    7. History of cerebrovascular accident within the past 6 months.
    8. No significant traumatic injury within the past 28 days.
  16. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
  17. Patients with known HIV.
  18. Patients with chronic Hepatitis B and C infection.
  19. Patients with uncontrolled autoimmune diseases.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01551745
CL-PTL 112
Yes
Not Provided
Not Provided
Gradalis, Inc.
Gradalis, Inc.
Not Provided
Principal Investigator: Minal Barve, MD Mary Crowley Cancer Research Centers
Gradalis, Inc.
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP