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

Ovarian Cancer Clinical Trial

Official title:

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091273
• Other study ID #: 11276
• Secondary ID: UVACC-OVA3UVACC-
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2004
• Last updated: May 19, 2014
• Start date: June 2004
• Est. completion date: June 2007

Study information

• Verified date: May 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2007
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• incomplete Freund's adjuvant

• ovarian cancer peptide vaccine

• sargramostim

• tetanus toxoid helper peptide

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	University of Virginia Cancer Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the Vaccine	Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.	Days 1,8,15,22,29,36,43,50	Yes
Primary	Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay		Day 22	No
Secondary	Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay		Days 1,8,15,22,29,36,43,50 and Month 3	No