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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: incomplete Freund's adjuvant
* Biological: ovarian cancer peptide vaccine
* Biological: sargramostim
* Biological: tetanus toxoid helper peptide
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: incomplete Freund's adjuvant|nan|
|Biological: ovarian cancer peptide vaccine|nan|
|Biological: sargramostim|nan|
|Biological: tetanus toxoid helper peptide|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Vaccine | 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 |  | Day 22 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer