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Phase 1 N=9 Treatment

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

Ovarian Cancer · Primary Peritoneal Cavity Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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