Ovarian Cancer Vaccine for Patients in Remission

Completed · Phase 2

Conditions studied: Epithelial Ovarian Cancer

In brief

The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning. Study objectives Primary objectives: * To confirm the safety of administering Cvac in this population. * To determine the effects of Cvac on progression-free survival (PFS). Secondary objectives: * To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting. * Evaluation of host immunologic response to Cvac administration.

Key facts

Study ID

NCT01068509

Run by

Prima BioMed Ltd

People needed

63

Starts

2010-07-01

Expected to finish

2015-04-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Marin Cancer Care, Inc. — Greenbrae, California, United States
• Scripps Cancer Center — La Jolla, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Collaborative Research Group — Boca Raton, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• New York Downtown Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia
• Gold Coast Hospital — Southport, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Cetnre — East Melbourne, Victoria, Australia
• Austin Health Cancer Centre — Heidelberg, Victoria, Australia

Full record on ClinicalTrials.gov

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