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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amir Jazaeri, University of Virginia
ClinicalTrials.gov Identifier:
NCT00091273
First received: September 7, 2004
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: incomplete Freund's adjuvant
Biological: ovarian cancer peptide vaccine
Biological: sargramostim
Biological: tetanus toxoid helper peptide
Procedure: adjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Safety of the Vaccine [ Time Frame: Days 1,8,15,22,29,36,43,50 ] [ Designated as safety issue: Yes ]
    Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.

  • Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091273

Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Amir A. Jazaeri, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Amir Jazaeri, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT00091273     History of Changes
Other Study ID Numbers: 11276, UVACC-OVA3, UVACC-33204
Study First Received: September 7, 2004
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014