Ovarian Cancer Vaccine for Patients in Remission

NCT ID: NCT01068509

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-04-30

Brief 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.

Detailed Description

An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-randomized Cvac

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.

Group Type: EXPERIMENTAL

Cvac

Intervention Type: BIOLOGICAL

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.

Randomized Cvac

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.

Group Type: EXPERIMENTAL

Cvac

Intervention Type: BIOLOGICAL

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.

Observational standard of care

Participants in this group did not receive any treatment during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cvac

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prima BioMed Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Gray, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Mark Moradi, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital

Jonathan Berek, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Nana Tchabo, MD

Role: PRINCIPAL_INVESTIGATOR

Morristown Medical Center

Jennifer Young, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

James Mason, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Cancer Center

Angeles Secord, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Peter Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Marin Cancer Care

Giuseppe Del Priore, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Peter Rose, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Fernando Recio, MD

Role: PRINCIPAL_INVESTIGATOR

Collaborative Research Group

Benedict Benigno, MD

Role: PRINCIPAL_INVESTIGATOR

Northside Hospital

John Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Paul Mitchell, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Austin Health Cancer Care

Linda Mileshkin, MBBS

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Margaret Davy, MBBS, CGO

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Jeffrey Goh, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Greenslopes Private Hospital

Marco Matos, FRACP

Role: PRINCIPAL_INVESTIGATOR

Gold Coast Hospital

Locations

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

Countries

United States; Australia

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Related Links

http://primabiomed.com.au/investor/presentations.php

Related Info from Sponsor's Web Site

Other Identifiers

CAN-003

Identifier Type: -

Identifier Source: org_study_id