Ovarian Cancer Vaccine for Patients in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd
ClinicalTrials.gov Identifier:
NCT01068509
First received: February 10, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Biological: MUC1 Dendritic Cell Vaccine (Cvac)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Prima BioMed Ltd:

Primary Outcome Measures:
  • To evaluate the safety of Cvac administration in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    For eligible patients that have completed or terminated the study, the collection of Overall Survival data will continue through October 2015.

  • Evaluation of immunologic parameters subsequent to Cvac administration. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: June 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Patients will be receiving MUC1 Dendritic Cell Vaccine (Cvac) treatment.
Biological: MUC1 Dendritic Cell Vaccine (Cvac)
Patients will receive vaccinations every four weeks for 24 weeks followed by injections every eight weeks for an additional 24 weeks.
Other Name: Cvac
No Intervention: Observational standard of care
Patients will be under observation, no anti-cancer treatment will be given to this group.

Detailed Description:

STUDY OBJECTIVES:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068509

Locations
United States, California
Marin Cancer Care, Inc.
Greenbrae, California, United States, 94904
Scripps Cancer Center
La Jolla, California, United States, 92037
Stanford University School of Medicine
Palo Alto, California, United States, 94305
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Florida
Collaborative Research Group
Boca Raton, Florida, United States, 33487
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07962
United States, New York
New York Downtown Hospital
New York, New York, United States, 10038
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98109
Australia, Queensland
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Gold Coast Hospital
Southport, Queensland, Australia, 4215
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Cetnre
East Melbourne, Victoria, Australia, 3002
Austin Health Cancer Centre
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Prima BioMed Ltd
Investigators
Principal Investigator: Heidi Gray, MD University of Washington
Principal Investigator: Mark Moradi, MD New York Downtown Hospital
Principal Investigator: Jonathan Berek, MD, MMS Stanford University
Principal Investigator: Nana Tchabo, MD Morristown Medical Center
Principal Investigator: Jennifer Young, MD Medical University of South Carolina
Principal Investigator: James Mason, MD Scripps Cancer Center
Principal Investigator: Angeles Secord, MD Duke University
Principal Investigator: Peter Eisenberg, MD Marin Cancer Care
Principal Investigator: Giuseppe Del Priore, MD Indiana University Simon Cancer Center
Principal Investigator: Peter Rose, MD The Cleveland Clinic
Principal Investigator: Fernando Recio, MD Collaborative Research Group
Principal Investigator: Benedict Benigno, MD Northside Hospital
Principal Investigator: John Chan, MD University of California, San Francisco
Principal Investigator: Paul Mitchell, MB ChB Austin Health Cancer Care
Principal Investigator: Linda Mileshkin, MBBS Peter MacCallum Cancer Centre, Australia
Principal Investigator: Margaret Davy, MBBS, CGO Royal Adelaide Hospital
Principal Investigator: Jeffrey Goh, MBBS, FRACP Greenslopes Private Hospital
Principal Investigator: Marco Matos, FRACP Gold Coast Hospital
  More Information

Publications:
Jemal A, Siegel R, Ward E, et al: Cancer Statistics, 2008. CA Cancer J Clin 2008; 58:71 96.
Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.

Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01068509     History of Changes
Other Study ID Numbers: CAN-003
Study First Received: February 10, 2010
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Prima BioMed Ltd:
Cvac

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 14, 2014