Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer

Official Title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine Encoding the Amino Acids 1-163 of Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) in Patients With Advanced Ovarian Cancer

Study ID: NCT01322802

Conditions

Stage III Ovarian Epithelial Cancer

Stage III Ovarian Germ Cell Tumor

Stage IV Ovarian Epithelial Cancer

Stage IV Ovarian Germ Cell Tumor

Interventions

pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

laboratory biomarker analysis

Study Description

Brief Summary: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer. SECONDARY OBJECTIVES: I. To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer. II. To determine whether intermolecular epitope spreading occurs with the generation of an IGFBP-2 specific Th1 immune response. III. To determine whether IGFBP-2 vaccination modulates T regulatory cells. OUTLINE: Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID) monthly for 3 months. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then every 6 months for 5 years.