A Trial of FANG™ Vaccine for Participants With Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Biological: Vigil™
- Registration Number
- NCT01309230
- Lead Sponsor
- Gradalis, Inc.
- Brief Summary
This was a clinical trial for women with ovarian cancer scheduled to have an operation to remove the cancerous tissue. The cancer cells removed during the planned surgery were used to attempt to make the investigational product, named Vigil. Vigil is considered an immunotherapy. In this study, participants who met the requirements to be in the study and if Vigil was successfully made from the participants cancer cells, participants underwent treatment with their standard chemotherapy regimen. At the end of the standard chemotherapy regimen and if there was no evidence of remaining cancer, participants were randomly assigned to receive the Vigil or would be assigned to the standard of care group, which in this study meant no further treatment was given to the participant.
The purpose of this study was to compare the difference between the participants who received Vigil versus the usual care after completion of standard chemotherapy and to determine if Vigil delayed or prevented ovarian cancer from coming back.
- Detailed Description
This was a Phase II open-label study of Vigil™ autologous tumor cell vaccine trial administered to women with Stage III/IV epithelial ovarian cancer. Tumor was harvested at the time of surgical debulking (standard of medical care). Participants who achieved clinical complete response (CR) following primary surgical debulking and front-line doublet chemotherapy were randomized 2:1 to either treatment with Vigil (Group A) or standard of care without maintenance therapy (Group B). After randomization, participants were stratified into cohorts by baseline CA-125 (greater than 10 to less than 20 units/mL versus less than or equal to 10 units/mL). For data analysis, participants could further be stratified by surgical stage (Stage IV or suboptimal debulking (\> 1cm residual), Stage III disease versus Stage III disease with optimal debulking (\< 1cm residual). Participants enrolled in Group A (Vigil) received 1.0 x 10e7 cells / intradermal injection of gene transfected autologous tumor cells, Vigil™, once a month for up to 12 doses as long as sufficient material was available or until trial endpoints were met. Enough harvested tissue to provide a minimum of 4 monthly injections was required for entry into the study. Participants enrolled in Group B (Standard of Care, SOC) were observed and assessed until trial endpoints were met. Protocol Amendment 8, June 19, 2014 removed randomization such that all patients screening for enrollment into the main portion of the trial (including those who previously had tumor tissue harvested) would be assigned to Group A (Vigil).
Both groups of participants were seen once a month in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes were monitored monthly. Immune function analysis including ELISPOT analysis of cytotoxic T cell function to autologous tumor antigens were monitored at (≤ 24 hours before the third cycle chemotherapy (post debulking), baseline (screening); prior to Vigil injection at Months 2, 3, 6 and EOT. CA-125 was monitored at baseline, every month for the first year, every 3 months +/- 2 weeks for the second and third year.
Participants assigned to group A were allowed to continue treatment with Vigil 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) developed related to study treatment, the vaccine dose was reduced by 50% and continued on a monthly basis.
Efficacy assessments included time to disease recurrence, immune surrogate markers, and quality of life questionnaire (FACT-O, Version 4). Safety assessments included physical examination, performance status, and vital signs. Adverse events were recorded using CTCAE version 3.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Vigil™) Vigil™ Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.
- Primary Outcome Measures
Name Time Method Time to Recurrence (TTR) Treatment start to the date of first recurrence or date of death if the participant died before recurrence. Radiographic assessment at baseline, </= 1 week prior to Cycle 4, at Standard of Care intervals, and when CA-125>35 U/mL, approximately 3 years. Time to recurrence is the time to progression by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. Disease recurrence was defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels \>35 U/mL at two consecutive measurements, at least one month apart.
- Secondary Outcome Measures
Name Time Method Predictive Potential of Tumor Infiltrating Lymphocyte (TIL) and Tumor Associated Macrophage (TAM) Phenotypes From tissue procurement until recurrence. Predictive potential for TIL and TAM was expected to be measured from tissue collected at baseline and at recurrence.
Number of Participants Positive for T-cell and Immune Activation Markers Blood was collected at tissue procurement, prior to the 1st and 3rd cycles of chemotherapy post debulking, at screening, months 2, 4, 6, end of treatment, and quarterly until recurrence, up to 3 years. Gamma interferon (γ-IFN) secretion measured by ELISpot assay was used as a marker for T-cell and immune activation to cancer specific neoantigens. Any participant that had greater than or equal to 10 spots were considered positive.
Vigil Related Adverse Events (AEs) From first dose of Vigil until 30 days following last dose of Vigil, up to 13 months. AEs were reported using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Trial Locations
- Locations (7)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Texas Oncology - Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology - Fort Worth
🇺🇸Fort Worth, Texas, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States