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Trial record 10 of 13 for:    22186789 [PUBMED-IDS] AND intradermal

Phase 2 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer (VITAL)

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.
 
ClinicalTrials.gov Identifier: NCT02346747
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Gradalis, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2015
First Posted Date  ICMJE January 27, 2015
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Recurrence Free Survival [ Time Frame: 7-14 months after surgery and chemotherapy ]
The primary endpoint of Recurrence Free Survival is the time from the randomization date to either the date the subject is first recorded as having disease recurrence (even if the subject went off treatment because of toxicity), or the date of death if the subject dies due to any causes before recurrence.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
Recurrence Free Survival [ Time Frame: 7-14 months after sugery and chemotherapy ]
Change History Complete list of historical versions of study NCT02346747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2015)
Overall Survival [ Time Frame: 54 months ]
The assumed median survival in the control arm is 54 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Trial of Maintenance Vigil for High Risk Stage IIIb-IV Ovarian Cancer
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy
Brief Summary This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will manufactured. Subjects will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.
Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of maintenance Vigil Ovarian (gemogenovatucel-T) engineered autologous tumor cells (EATC) in women with Stage IIIb, IIIc or IV high-grade papillary serous/ clear cell / endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic / evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will be manufactured. Subjects will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.

Investigational treatment must start no less than 3 weeks and no more than 8 weeks following completion of chemotherapy.

Approximately 86 subjects will be randomized 1:1 to receive either monthly intradermal Vigil or placebo for at least 4 to a maximum of 12 administrations. Randomization will be stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. The objective is determining RFS of subjects randomized to Vigil versus placebo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Ovarian Neoplasms
Intervention  ICMJE
  • Biological: Vigil
    bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy
    Other Names:
    • bi-shRNAfurin and GMCSF Autologous Tumor Cell Immunotherapy
    • FANG Autologous Tumor Cell Immunotherapy
  • Biological: Placebo
    "freeze" media.
Study Arms  ICMJE
  • Active Comparator: Group A
    Group A will receive 1.0 x 10e7 cells of gene transfected, irradiated, autologous tumor cells via intradermal injection once a month.
    Intervention: Biological: Vigil
  • Placebo Comparator: Group B
    Group B will receive "freeze" media (10% DMSO, 1% human serum albumin in Plasma-Lyte) via intradermal injection once a month.
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 15, 2018)
91
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2015)
440
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Subjects will be eligible for tissue procurement for the Vigil manufacturing process if they meet all of the following criteria:

  1. Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer.
  2. No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil manufacture.
  3. No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  4. Anticipated availability of a cumulative mass of ~30 grams tissue ("golf-ball" size or approximately 3cm disease on CT scan) at time of diagnostic laparoscopy or primary surgical debulking. Infiltrating lumen (bowel, fallopian tube, urethra) tissue should not be used as Vigil immunotherapy material to minimize risk of bacterial contamination.
  5. ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy.
  6. No prior history of hypersensitivity reactions (HSR) with taxanes or platinums.
  7. No prior history of allergies or sensitivities to gentamicin.
  8. Female, 18 years of age or older.
  9. Ability to understand and the willingness to sign a written informed consent document for tissue harvest.

Subjects will be registered in this study if they meet all of the following inclusion criteria:

  1. Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal.
  2. Completion of primary surgical debulking including hysterectomy and bilateral salpingo oophorectomy, and at least 5 but no more than 8 cycles of platinum / taxane adjuvant chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines, including 5-8 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or 5-8 cycles of intravenous chemotherapy divided and administered as neoadjuvant and adjuvant therapy flanking primary debulking surgery.
  3. Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy. cCR defined as no evidence of malignancy on chest x-ray (CT scan is acceptable) and CT scan or MRI of the abdomen and pelvis, normal physical examination, CA-125 antigen level ≤ 35 U/ml (assessed ≥ 2 weeks following removal of catheter in subjects receiving intraperitoneal/intravenous chemotherapy) and no findings on physical examination or symptoms suggestive of active cancer.
  4. Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery.
  5. Successful manufacturing of at least 4 doses (vials) of Vigil and placebo.
  6. Recovered from all clinically relevant toxicities related to prior therapy (including neuropathy ≤Grade 2).
  7. ECOG performance status (PS) 0-1.
  8. Normal organ and marrow function as defined below: Absolute granulocyte count ≥ 1,500/mm^3, Absolute lymphocyte count ≥ 500/mm^3, Platelets ≥ 75,000/mm^3, Total bilirubin ≤ 2 mg/dL, AST(SGOT)/ALT(SGPT)≤ 2x institutional upper limit of normal, Creatinine < 1.5 mg/dL
  9. Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion Criteria:

Subjects will be excluded from this study if they meet any of the following criteria (at the time of tissue procurement or at randomization):

  1. Surgery involving general anesthesia, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to randomization.
  2. Histologically confirmed papillary serous adenocarcinoma of the uterus or disease involving myometrium/endometrium.
  3. Systemic immunosuppressive therapy within 14 days of randomization.
  4. Subjects requiring chronic steroid or immunosuppressive regimens are excluded except inhaled / intranasal steroids and short term systemic steroids <30 days duration and ≤0.25 mg/kg prednisone-equivalent per day are allowed.
  5. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months).
  6. Psychiatric illness/social situations that would limit compliance with study requirements.
  7. Subjects with history of brain metastases.
  8. Subjects with known HIV or chronic Hepatitis B or C infection.
  9. Prior solid organ or bone marrow transplant.
  10. History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or Graves disease). Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02346747
Other Study ID Numbers  ICMJE CL-PTL-119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gradalis, Inc.
Study Sponsor  ICMJE Gradalis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luisa Manning, MD Gradalis, Inc.
PRS Account Gradalis, Inc.
Verification Date August 2019

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