Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors
This is an open-label, single arm study evaluating a multi-peptide (tumor-associated antigens)/Montanide vaccine in patients < 21 years of age with recurrent or refractory CNS tumors. The study primarily evaluates the safety of this regimen. Secondarily, immunogenicity and anti-tumor effects will be assessed.
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
The secondary aims are to evaluate cellular immune responses induced in patients after subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in patients with measurable disease or time to progression in patients without measurable disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide ISA-51VG in Pediatric Patients With Recurrent or Refractory Central Nervous System Tumors|
- The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
- Evaluate cellular immune responses induced in pts after injection of TAA mixed with Montanide and document tumor response in pts w/ measurable disease or time to progression in pts without measurable disease following injection of TAA mixed w/ Montanide. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Experimental: Open Label||
Montanide is an oil-based immunoadjuvant similar to Incomplete Freund´s Adjuvant, which is commonly used in combination with peptide vaccines. Although its precise mode of action is not known, it acts to enhance the immune response to vaccination. It has a depot effect that depending on the type of emulsion will release the antigen slowly from the injection site.
Other Name: Montanide ISA-51 VG
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935545
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Sharon Gardner, MD||NYU Langone Medical Center|