Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00091273|
Recruitment Status : Completed
First Posted : September 9, 2004
Results First Posted : June 20, 2014
Last Update Posted : June 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: incomplete Freund's adjuvant Biological: ovarian cancer peptide vaccine Biological: sargramostim Biological: tetanus toxoid helper peptide Procedure: adjuvant therapy||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||June 2007|
- Safety of the Vaccine [ Time Frame: Days 1,8,15,22,29,36,43,50 ]Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
- Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay [ Time Frame: Day 22 ]
- Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay [ Time Frame: Days 1,8,15,22,29,36,43,50 and Month 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091273
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Amir A. Jazaeri, MD||University of Virginia|