Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT01322802
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2011-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer
Sponsor:
University of Washington
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-00099 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 134 | None | None | View | |
| 7396 | OTHER | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |
| RG7212000 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View |