Phase 1
N=9
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Ovarian Cancer · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00091273 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Safety of the Vaccine — 0; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- incomplete Freund's adjuvant (Biological); ovarian cancer peptide vaccine (Biological); sargramostim (Biological); tetanus toxoid helper peptide (Biological); adjuvant therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Virginia
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the Vaccine |
0; 9 | — |
| PRIMARY Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay |
8; 1 | — |
| SECONDARY Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay |
8; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00091273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.