Ovarian Cancer Vaccine for Patients in Remission
Epithelial Ovarian Cancer
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Cvac
Eligibility Criteria
Inclusion Criteria:
- Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
- Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125.
- Able and willing to undergo mononuclear cell collection.
- Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
- No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
- No prior treatment with an investigational product within 30 days of enrollment.
- Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
- Serum creatinine ≤ 2 mg/dL.
- Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal.
- White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
- Life expectancy of at least 12 months.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
- All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1.
- Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
- Able to provide written informed consent.
Exclusion Criteria:
- Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.
- Ovarian germ cell, sarcoma, or mixed Mullerian tumors.
- Prior cancer vaccine or cellular therapy.
- Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common Terminology Criteria for Adverse Events criteria.
- Inability to provide informed consent or to comply with study-related procedures.
- Concurrent systemic treatment with steroids or other immunosuppressive agents.
- Diagnosed immunodeficiency and/or autoimmune disorders.
- Myocardial infarction in the past 6 months and/or clinically significant heart disease.
- Infection with human immunodeficient virus (HIV), hepatitis B or C virus.
- Pregnant or breastfeeding.
- Evidence or history of central nervous system metastases.
- Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.
- Hematopoietic growth factors administered within 14 days of enrollment.
Sites / Locations
- Marin Cancer Care, Inc.
- Scripps Cancer Center
- Stanford University School of Medicine
- University of California, San Francisco
- Collaborative Research Group
- Northside Hospital
- Indiana University Simon Cancer Center
- Morristown Medical Center
- New York Downtown Hospital
- Duke University Medical Center
- Cleveland Clinic Foundation
- Medical University of South Carolina
- University of Washington Medical Center
- Greenslopes Private Hospital
- Gold Coast Hospital
- Royal Adelaide Hospital
- Peter MacCallum Cancer Cetnre
- Austin Health Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Non-randomized Cvac
Randomized Cvac
Observational standard of care
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
Participants in this group did not receive any treatment during the study.