Salvage Ovarian FANG Vaccine + Bevacizumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Gradalis, Inc.
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.
ClinicalTrials.gov Identifier:
NCT01551745
First received: March 1, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

This is a Phase II study of FANG™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had FANG™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive FANG™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.


Condition Intervention Phase
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Biological: FANG™ Vaccine
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gradalis, Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Participants will followed up to 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Progression [ Time Frame: Participants will be followed up to 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 6
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: FANG™ Vaccine
    Patients meeting eligibility criteria will receive FANG™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks.
    Other Name: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine
    Drug: Bevacizumab
    Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
    Other Name: VEGF
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 FANG™ vaccine.
  5. Recovered from all clinically relevant toxicities related to prior therapies.
  6. ECOG PS 0-2 prior to FANG™ 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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551745

Locations
United States, Texas
Mary Crowley Cancer Research Centers Recruiting
Dallas, Texas, United States, 75230
Contact: Referral Office    972-566-3000    referral@marycrowley.org   
Principal Investigator: Minal Barve, MD         
Sponsors and Collaborators
Gradalis, Inc.
Investigators
Principal Investigator: Minal Barve, MD Mary Crowley Cancer Research Centers
  More Information

Publications:
Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT01551745     History of Changes
Other Study ID Numbers: CL-PTL 112
Study First Received: March 1, 2012
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gradalis, Inc.:
Papillary Serous Ovarian Cancer
Endometrioid Ovarian Cancer
Epithelial Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014