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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)

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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.

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
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.
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

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.
Biological: Placebo
"freeze" media.




Primary Outcome Measures :
  1. 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.



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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02346747


  Hide Study Locations
Locations
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United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, California
Southern California Permanente Medical Group
Irvine, California, United States, 92618
California Pacific Medical Cencer Research Institute
San Francisco, California, United States, 94115
United States, Florida
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Dana Farber Cancer Institute: Gynecologic Oncology
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Duke University Medical Center, Department of Medicine - Oncology
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Stephenson Cancer Center at University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Luke's Health Network
Bethlehem, Pennsylvania, United States, 18015
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
GHS Cancer Institute
Greenville, South Carolina, United States, 29605
United States, Texas
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9032
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77230
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99216
Franciscan Research Center
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gradalis, Inc.
Investigators
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Study Director: Luisa Manning, MD Gradalis, Inc.

Publications:
Senzer N, Barve M, Nemunaitis J, Kuhn J, Melnyk A, et al. (2013) Long Term Follow Up: Phase I Trial of "Bi-Shrnafurin/GMCSF DNA/Autologous Tumor Cell" Immunotherapy (FANG™) in Advanced Cancer. J Vaccines Vaccin 4:209. doi: 10.4172/2157-7560.1000209

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Responsible Party: Gradalis, Inc.
ClinicalTrials.gov Identifier: NCT02346747     History of Changes
Other Study ID Numbers: CL-PTL-119
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gradalis, Inc.:
Stage III
Stage IV
Ovarian Cancer
Maintenance
Immunotherapy
primary peritoneal cancer
fallopian tube cancer
endometrioid ovarian cancer
high-grade serous ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Modafinil
Immunologic Factors
Physiological Effects of Drugs
Central Nervous System Stimulants
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action