Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

May 19, 2014 updated by: Amir Jazaeri, University of Virginia

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer.

OUTLINE: This is an open-label study.

Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43.

After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or primary peritoneal cancer

  • Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria:

    • Clinical or radiographic evidence of disease
    • Serologic evidence of disease
    • Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months

  • At least 2 intact axillary and/or inguinal lymph node basins

    • Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin
  • HLA-A1-, -A2-, or -A3-positive

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin > 8.0 g/dL OR
  • Hematocrit > 25%
  • Platelet count ≥ 80,000/mm^3

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal
  • Hepatitis C negative

Renal

  • Not specified

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Immunologic

  • HIV negative
  • No active infection requiring antibiotics
  • No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
  • No prior autoimmune disorder with visceral involvement
  • No known or suspected allergy to any component of the study vaccine

  • The following immunologic conditions are allowed:

    • Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic
    • Clinical evidence of vitiligo or other forms of depigmenting illness
    • Mild arthritis requiring non-steroidal anti-inflammatory drugs

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Weight ≥ 110 lbs
  • No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%
  • No active hyperthyroidism
  • No current or recent (within the past year) addiction to alcohol or drugs
  • No medical contraindication or other potential medical problem that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior and no concurrent allergy desensitization injections
  • More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim)
  • More than 1 month since prior and no other concurrent immunotherapy

  • More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following:

    • Interferon
    • Tumor necrosis factor
    • Interleukins or other cytokines
    • Biologic response modifiers
    • Monoclonal antibodies
  • No prior vaccination with all of the study peptides relevant to the patient's HLA-type

Chemotherapy

  • See Disease Characteristics
  • More than 1 month since prior chemotherapy and recovered
  • No concurrent cytotoxic chemotherapy

Endocrine therapy

  • More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol)

    • Topical corticosteroids allowed

Radiotherapy

  • More than 1 month since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • More than 1 month since prior surgery and recovered

Other

  • More than 1 month since other prior treatment and recovered
  • More than 1 month since prior and no other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the Vaccine
Time Frame: Days 1,8,15,22,29,36,43,50
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Days 1,8,15,22,29,36,43,50
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Time Frame: Day 22
Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
Time Frame: Days 1,8,15,22,29,36,43,50 and Month 3
Days 1,8,15,22,29,36,43,50 and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Amir A. Jazaeri, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

February 1, 2006

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 7, 2004

First Submitted That Met QC Criteria

September 8, 2004

First Posted (ESTIMATE)

September 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11276
  • UVACC-OVA3
  • UVACC-33204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on adjuvant therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe