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Treatment Name: |
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A Pilot Study to Evaluate the Effects of Vaccinations with HLA-A2-Restricted Glioma Antigen-Peptides in Combination with Poly-ICLC for Children with Newly Diagnosed Malignant or Intrinsic Brain Stem Gliomas (BSG) or Incompletely Resected Non-Brainstem High-Grade Gliomas (HGG) or Recurrent Unresectable Low-Grade Gliomas (LGG) or Recurrent High Grade Gliomas |
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Phase: |
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Phase 1 |
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Treatment ID#: |
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1897 |
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Age Group: |
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Pediatric Only |
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Min Karnofsky Score: |
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Not Specified |
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Conditions: |
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Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed
Age 3 to 20 |
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Last Updated: |
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09/23/2009 |
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Tumor Types: |
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Anaplastic Astrocytoma
Brainstem Glioma
Glioblastoma Multiforme
Low Grade Glioma
Pediatric Brain Tumors |
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Comments: |
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Patients are stratified according to tumor type and location:
Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma involving the brainstem.
Stratum B: Newly diagnosed incompletely resected non-brainstem high-grade gliomas.
Stratum C: Unresectable progressive low-grade gliomas.
Stratum D: Recurrent high-grade gliomas that have recurred following treatment.
Stratum E: Newly diagnosed unresectable high-grade gliomas or brain stem gliomas who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after radiation therapy was completed.
Patients in Stratum A, Stratum B and Stratum E begin treatment 4-12 weeks after fractionated external beam radiotherapy (FEBRT) given off study. All patients receive HLA-A2-restricted synthetic glioma antigen-peptides vaccine subcutaneously and poly ICLC vaccine intramuscularly. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with complete, partial response or stable disease may receive additional peptide and poly-ICLC vaccinations beginning 6 weeks after the 8th vaccination and continuing every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Blood samples for glioma-associated antigen (GAA) expression and GAA-specific T-cell-response analysis by ELISPOT assay will be collected every 8-12 weeks. If available, tissue samples will be collected either at baseline (pre-vaccines), after progression (post-vaccines), or both for GAA expression analysis by immunohistochemistry and reverse transcriptase-PCR assays. Tumor-infiltrated leukocytes are evaluated pre- and post-therapy via flow cytometry. For more details, go to: http://www.cancer.gov/clinicaltrials/CHP-PRO08030085
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Treatment Type: |
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Less-Toxics
Immunological, Biological or Targeted Therapy |
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Contact: |
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Regina Jakacki MD
Children`s Hospital of Pittsburgh
Pittsburgh, PA 15213 USA
Phone: 412-692-5055
Fax:
E-mail: regina.jakacki@chp.edu
Website: |
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