Trials / Completed
CompletedNCT01322802
Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Stage III Ovarian Epithelial Cancer
- Stage III Ovarian Germ Cell Tumor
- Stage IV Ovarian Epithelial Cancer
- Stage IV Ovarian Germ Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine | Given ID |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2012-03-06
- Primary completion
- 2015-01-09
- Completion
- 2020-12-01
- First posted
- 2011-03-25
- Last updated
- 2021-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01322802. Inclusion in this directory is not an endorsement.