Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Molgramostim

Sargramostim

Vaccines

Freund's Adjuvant

Immunologic Factors

Adjuvants, Immunologic

incomplete Freund's adjuvant

ovarian cancer peptide vaccine

sargramostim

tetanus toxoid helper peptide

adjuvant therapy

Amir A. Jazaeri, MD

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.

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.

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

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

Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.

National Cancer Institute (NCI)

University of Virginia

Principal Investigator

Single Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Craig L. Slingluff, MD

# of Subjects Experiencing a DLT

# of Subjects Not Experiencing a DLT

Safety of the Vaccine

Responders

Non-responders

Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay

Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay

Overall Study

Spots Global Cancer Trial Database for ovarian cancer peptide vaccine