Completed

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

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What is being tested

Data Collection

Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorUniversity of Virginia
Last updated: December 11, 2025
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Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer 
NCT00091273
Principal SponsorUniversity of Virginia
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Virginia Cancer Center

Charlottesville, United StatesSee the location
CompletedOne Study Center