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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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 disease

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Amir A. Jazaeri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000386176

NCT ID:

NCT00091273

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908