Tumors, Central Nervous System Clinical Trial
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
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04351035 -
National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry
|