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Trial of Adjuvant FANG™ Vaccine for High Risk Stage III/IV Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309230
Recruitment Status : Active, not recruiting
First Posted : March 7, 2011
Last Update Posted : October 18, 2021
Information provided by (Responsible Party):
Gradalis, Inc.

Brief Summary:
This is a Phase II open-label trial of maintenance Vigil™ autologous tumor cell vaccine. Tumor will be harvested at the time of surgical debulking (standard of medical care). Subsequently, patients achieving clinical CR following primary surgical debulking and doublet chemotherapy will be stratified for i) surgical stage (Stage IV or suboptimal debulking (>1 cm residual) Stage III disease versus Stage III patients with optimal debulking (<1 cm residual)) and ii) post-op chemotherapy, pre-vaccine CA-125 >10 ≤ 20 U/mL versus 0≤10 U/ml. (Note: patients with Stage IIIc ovarian cancer will be additionally evaluated as a subset using descriptive statistics only). Patients will receive 1.0 x 10^7 cells / intradermal injection of gene transfected autologous tumor cells, Vigil™ once a month for up to 12 doses as long as sufficient material is available. Enough harvested tissue to provide a minimum of 4 monthly injections will be required for entry into the study. Hematologic function, liver enzymes, renal function and electrolytes will be monitored monthly. Immune function analysis including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens will be monitored at (≤24 hours before) tissue harvest, ≤24 hours before the first cycle of chemotherapy (post debulking), ≤24 hours before the third cycle of chemotherapy (post debulking), baseline (screening), prior to Vigil™ injection Months 2, 4, 6 and at EOT. The dates of the last dose of chemotherapy and the administration of Vigil™ vaccine #1 will be recorded. Treatment will be continued until disease recurrence or exhaustion of the patient's vaccine supply. If ≥ Grade 2 toxicity by NCI Common Toxicity Criteria (excluding Grade 2 fever ≤ 24 hours and Grade 2 and 3 injection site reactions) develops related to study treatment the vaccine dose will be reduced by 50% and continued on a monthly basis. If a single patient develops ≥ Grade 3 toxicity (other than injection site reaction) related to study treatment the trial will be placed on hold for reevaluation of design in discussion with FDA. During this hold, no new subjects will initiate dosing, but subjects already being dosed may continue dosing as scheduled if deemed clinically appropriate by the PI.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: Vigil™ Phase 2

Detailed Description:
Despite a gradual improvement in their overall survival over the past decade, approximately 75% of women with Stage IIIC ovarian cancer who achieve a complete clinical response will relapse as will 50% of those achieving pathologic complete response at a median time of 18-24 months. Phase III studies of both maintenance and consolidation therapeutic interventions have not translated into an overall survival advantage. Preliminary studies of immunotherapy in patients with ovarian cancer suggest target accessibility (potential immunogenicity) to immune mediated approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, we designed a novel autologous whole cell vaccine, Vigil™, incorporating the rhGMCSF transgene and the bifunctional shRNA^furin (to block proprotein conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen→immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune resistance. A Phase I assessment of Vigil™ vaccine in 33 advanced solid tumor patients (1 of them being a pediatric patient 15 years of age) receiving ≥1 vaccination (at a dose of 1.0 x 10^7 or 2.5 x 10^7 cells/injection/month for a maximum of 12 vaccinations) demonstrated safety of the Vigil™ vaccine. Furthermore, proof of principle was established in the manufactured vaccines with increased mean GMCSF expression post-transfection to 1135 pg/10^6 cells/ml and knockdown of furin, TGFb1 and TGFb2 at 78%, 93%, and 95%, respectively). In addition, although a Phase I study, the data suggested an overall survival benefit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer
Actual Study Start Date : February 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Vigil™
intradermal autologous Vigil™ (1.0 x 10^7 cells/injection; maximum of 12 vaccinations)
Biological: Vigil™
intradermal autologous Vigil™ (1.0 x 10^7 cells/injection; maximum of 12 vaccinations)
Other Name: formerly known as FANG™

Primary Outcome Measures :
  1. To determine and compare time to recurrence (TTR) [ Time Frame: Participants will be followed for life. ]

    Primary Objective(s):

    • To assess time to recurrence (TTR) following the administration of bi-shRNAfurin and GMCSF autologous tumor cell (Vigil™) vaccine.

Secondary Outcome Measures :
  1. Immune Function [ Time Frame: Blood will be collected at baseline, Months 2, 4, 6, and EOT ]

    Secondary Objectives:

    • To identify and determine the effect of Vigil™ autologous tumor cell vaccine on immune surrogate markers.
    • To assess the predictive potential of initial tumor infiltrating lymphocyte (TIL) and tumor associated macrophage (TAM) phenotypes.
    • To enlarge the safety database of Vigil™ autologous tumor cell vaccine in patients with minimal disease.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Tissue Procurement Inclusion Criteria:

  1. Presumptive Stage III/IV papillary serous or endometrioid ovarian cancer.
  2. Per Amendment #8, treatment naïve, high risk ovarian cancer will no longer be stratified, but the following information will be collected:

    1. Stage IV or suboptimal (>1 cm residual) Stage III disease versus Stage III patients with optimal (≤1 cm residual) disease,
    2. CA-125 ≤10 U/ml versus CA-125 greater than 10 but less than or equal to 20 U/ml
    3. IP chemotherapy versus IV chemotherapy
  3. Availability of "golf-ball" size 10-30 grams tissue at time of primary surgical debulking.
  4. ECOG performance status (PS) 0-2 prior to tumor debulking laparotomy.
  5. Ability to understand and the willingness to sign a written informed consent document for tissue harvest.


  1. Histologically confirmed Stage III/IV papillary serous or endometrioid ovarian cancer.
  2. Clinically defined CR (no cancer related symptoms, normal physical examination and CT scan abdomen/pelvis and CXR, and CA-125 ≤20 U/ml) following completion of primary surgical debulking. Patients enrolled must complete at least 5 but no more than 6 cycles platinum/taxane adjuvant or interval debulking + chemotherapy (or chemotherapy as per recommendations of NCCN guidelines, category 1 (IP chemotherapy included)).

    (Patients who complete surgery/chemotherapy with a CA-125 >20 U/mL pre-registration have the option of being followed up to 2 months if serial CA-125 values continue to decrease at a rate of CA-125 decrease of 50% per month.)

  3. Successful manufacturing of 4 vials of Vigil™ vaccine.
  4. Recovered from all clinically relevant toxicities related to prior protocol specific therapies (including neuropathy to ≤Grade 2).
  5. ECOG performance status (PS) 0-1.
  6. Normal organ and marrow function as defined below:

    Absolute granulocyte count ≥ 1,500/mm3 Absolute lymphocyte count ≥ 200/mm3 Platelets ≥ 75,000/mm3 Total bilirubin ≤ 2 mg/dL AST(SGOT)/ALT(SGPT) ≤ 2x institutional upper limit of normal Creatinine < 1.5 mg/dL

  7. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  8. Ability to understand and the willingness to sign a written informed protocol specific consent document.


  1. Surgery involving general anesthesia, radiotherapy, or immunotherapy within 4 weeks prior to randomization. Chemotherapy within 3 weeks prior to Vigil™ vaccine administration. Steroid therapy within 1 week prior to vaccine administration.
  2. Patient must not have received any other investigational agents within 4 weeks vaccine administration.
  3. Patients with history of brain metastases.
  4. Patients with compromised pulmonary disease.
  5. 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.
  6. Prior splenectomy.
  7. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in-situ cervix) unless in remission for ≥ 2 years.
  8. Kaposi's Sarcoma.
  9. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  10. Patients with known HIV.
  11. Patients with chronic Hepatitis B and C infection.
  12. Patients with uncontrolled autoimmune diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309230

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United States, Florida
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, New Hampshire
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, Texas
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Texas Oncology - Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Gradalis, Inc.
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Principal Investigator: Minal Barve, MD Investigator
Publications of Results:
Other Publications:

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Responsible Party: Gradalis, Inc. Identifier: NCT01309230    
Other Study ID Numbers: CL-PTL 105
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gradalis, Inc.:
Stage III
Stage IV
epithelial ovarian cancer
ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type