Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Primary Peritoneal Cavity Cancer
Intervention: incomplete Freund's adjuvant; ovarian cancer peptide vaccine; sargramostim; tetanus toxoid helper peptide; adjuvant therapy
Intervention MeSH terms: Sargramostim; Freund's Adjuvant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; primary peritoneal cavity cancer

Summary:

      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.
    

Eligibility 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