Know Cancer

forgot password

A Randomized, Open-Label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac) for Epithelial Ovarian Cancer Patients in First or Second Remission

Phase 2
18 Years
Open (Enrolling)
Epithelial Ovarian Cancer

Thank you

Trial Information

A Randomized, Open-Label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac) for Epithelial Ovarian Cancer Patients in First or Second Remission


The purpose of this trial is to determine the safety and efficacy of Cvac compared with
Observational Standard of Care in ovarian cancer patients who are in remission after first
or second-line therapy.

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.

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).

- CA-125 ≤ upper limit of normal with a prior history of an elevated CA-125.

- Able and willing to undergo MNC 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/mm3. (These CBC 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

- 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

- Hematopoietic growth factors administered within 14 days of enrollment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of Cvac administration in this population.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Heidi Gray, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

October 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Cvac
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



Cleveland Clinic Foundation Cleveland, Ohio  44195
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of Washington Medical Center Seattle, Washington  98195-6043
Stanford University School of Medicine Stanford, California  94305-5317
University of California, San Francisco San Francisco, California  94143
Duke University Medical Center Durham, North Carolina  27710
Scripps Cancer Center La Jolla, California  92037
Northside Hospital Atlanta, Georgia  30342
New York Downtown Hospital New York, New York  10038
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Collaborative Research Group Boynton Beach, Florida  33435
Marin Cancer Care, Inc. Greenbrae, California  94904
Morristown Medical Center Morristown, New Jersey  07962-1956