DFC_CL-OVA-P01-00-US (Aivita)

DFC CL-OVA-P01-00-US (Aivita) - 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

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
Phase II
Richard Friedman, M.D.
Aivita Biomedical, Inc.
Rhonda Crutcher
  • Disney Family Cancer Center (DFCC)
  • Providence Los Angeles Research Center