Ovarian Cancer Clinical Trial

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

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00091273

Recruitment Status:

Completed

Sponsor:

University of Virginia

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There is 1 Location for this study

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University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00091273

Recruitment Status:

Completed

Sponsor:


University of Virginia

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