Clinical trial NCT00091273: Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Official title: Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-09-09
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 with ovarian epithelial or primary peritoneal cancer.

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 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.

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

Primary outcomes:
measure: Safety of the Vaccine
timeFrame: Days 1,8,15,22,29,36,43,50
measure: Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
timeFrame: Day 22
Secondary outcomes:
measure: Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
timeFrame: Days 1,8,15,22,29,36,43,50 and Month 3
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Amir A. Jazaeri, MD
role: PRINCIPAL_INVESTIGATOR
References: