Ovarian Cancer Vaccine for Patients in Remission
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Cvac
Intervention description: Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cvac

Summary:

      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.
    

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.