A Phase I Study of NY-ESO-1 Overlapping Peptides (OLP4) Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer (EOC), Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission
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|ClinicalTrials.gov Identifier: NCT00616941|
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : April 18, 2012
This is an open label, Phase I study of vaccination with NY-ESO-1 OLP4 with or without immunoadjuvant Montanide and Poly-ICLC in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission.
The primary and secondary endpoints of the study are to determine the safety and immunogenicity of NY-ESO-1 OLP4 vaccination with or without immunoadjuvants Montanide and Poly-ICLC.
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Biological: NY-ESO-1 OLP4 Biological: NY-ESO-1 OLP4 + Montanide Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of NY-ESO-1 Overlapping Peptides (OLP4) With or Without Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer (EOC), Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission|
|Study Start Date :||August 2008|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2011|
Biological: NY-ESO-1 OLP4
1 mg of NY-ESO-1 OLP4 will be diluted in 0.5 mL of D5W and administered subcutaneously as a single injection.
Biological: NY-ESO-1 OLP4 + Montanide
1 mg of NY-ESO-1 OLP4 will be diluted in 0.5 mL of D5W, mixed with 0.5mL of Montanide and administered subcutaneously as a single injection.
Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC
1 mg NY-ESO-1 OLP4 + 1.4 mg Poly-ICLC emulsified in 1 mL Montanide and administered subcutaneously as two injections.
- To assess the safety of repeated vaccination with NY-ESO-1 overlapping peptides (4) (OLP4) with or without immunoadjuvants Montanide and Poly-ICLC. [ Time Frame: 16 weeks ]
- To evaluate the immune response (NY-ESO-1 antibody, CD4+ and CD8+ cells) induced by NY-ESO-1 OLP4 vaccine with or without immunoadjuvants Montanide and Poly-ICLC. [ Time Frame: 16 Weeks ]
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): NCT00616941
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Paul Sabbatini, MD||Memorial Sloan Kettering Cancer Center|