Status:
COMPLETED
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed 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 Montanid...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00091273
Start Date
June 1 2004
End Date
June 1 2007
Last Update
June 20 2014
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908