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Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas

This study is currently recruiting participants.
Verified December 2017 by Aivita Biomedical, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02033616
First Posted: January 13, 2014
Last Update Posted: December 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Aivita Biomedical, Inc.
  Purpose

This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient PMBC were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).

The primary endpoint of this trial is death from any cause with the metric of OS from the date of randomization. PFS will be a secondary endpoint and will be calculated as the time from the date of randomization for treatment until subjective tumor progression or death. Progression will be subjectively defined by the treating physician, and is expected to be based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of debulking surgery.

Patients will be stratified into (1) no evidence of disease (NED) (no measurable or non-measurable disease per RECIST and normal CA-125 levels) or (2) non-NED (measurable or non-measurable disease per RECIST or elevated CA-125 levels).


Condition Intervention Phase
Stage III Ovarian Carcinoma Stage IV Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Biological: AVOVA-1 Biological: MC Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Double-Blind, Randomized Trial Of AVOVA-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens) Vs. Autologous Peripheral Blood Mononuclear Cells (MC) In Patients With Stage III Or IV Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma After Primary Therapy

Resource links provided by NLM:


Further study details as provided by Aivita Biomedical, Inc.:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Overall Survival [ Time Frame: 5 years ]
    Overall Survival: time to death from date of randomization


Estimated Enrollment: 99
Actual Study Start Date: November 18, 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVOVA-1
Autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells. AVOVA-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.
Biological: AVOVA-1
Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.
Placebo Comparator: MC
Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection.
Biological: MC
Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • ECOG performance status of 0-1 (Karnofsky score of 70-100%)
  • Successful establishment of an autologous epithelial ovarian, fallopian tube, or primary peritoneal cancer cell line by AIVITA Biomedical, Inc.
  • Patients must previously have been staged as having stage III [intraperitoneal (IP)] or Stage IV (distant metastatic) ovarian, fallopian tube, or primary peritoneal cancer, have undergone surgical debulking, and have initiated or completed standard adjuvant chemotherapy, which may include intravenous (IV) and/or IP chemotherapy using standard regimens. Patients will be characterized as being NED or non-NED per physical exam, CT and/or PET scans, and CA-125.
  • Have undergone leukapheresis from which sufficient provided PBMC were obtained to produce an investigational treatment.
  • Patients with one or a few brain metastases that have been treated with stereotactic radiotherapy consisting of a single dose, such as Gamma Knife or Cyberknife, are allowed to be included in the study, but need wait one week after such treatment.
  • Written informed consent for treatment with investigational treatment

Exclusion Criteria:

  • Known to have active hepatitis B or C or HIV
  • ECOG performance status greater than 1 (Karnofsky score less than 70%).
  • Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
  • Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than ovarian (such as continuation of hormonal therapy for prostate or breast cancer diagnosed more than five years earlier).
  • Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
  • Active central nervous system metastases at the time of treatment.
  • Known autoimmune disease, immunodeficiency, or disease process that involves the use of immunosuppressive therapy.
  • Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment.
  • Known hypersensitivity to GM-CSF
  Contacts and Locations
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): NCT02033616


Contacts
Contact: Candace Hsieh, PhD 949-872-2555 ext 110 candace@aivitabiomedical.com

Locations
United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92658
Contact: Leila Andres, MS    949-764-5543    leila.andres@hoag.org   
Principal Investigator: Lisa Abaid, MD         
Sub-Investigator: Alberto Mendivil, MD         
Sub-Investigator: John (Jeb) Brown, MD         
Sub-Investigator: Kristina Mori, MD         
Sponsors and Collaborators
Aivita Biomedical, Inc.
Investigators
Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.
  More Information

Responsible Party: Aivita Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02033616     History of Changes
Other Study ID Numbers: CL-OVA-P01
First Submitted: January 7, 2014
First Posted: January 13, 2014
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases