A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gl… (NCT01130077) | Clinical Trial Compass
CompletedPhase 1
A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas
United States60 participantsStarted 2009-02
Plain-language summary
The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.
Who can participate
Age range12 Months – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\*\*Inclusion Criteria
\*Tumor Types - Tumor type/location:
Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma\* involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)
Stratum B: Newly diagnosed, non-brainstem high-grade glioma\* Patients may not have received chemotherapy during or after radiation. (Note: Stratum B is open to accrual.)
Stratum C: Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Patients may not have received radiation to the index lesion within 1 year of enrollment. (Note: Stratum C is closed to accrual.)
Stratum D: Non-brainstem high-grade gliomas\* that have recurred following treatment. (Note: Stratum D is closed to accrual.)
Stratum E: Newly diagnosed high-grade gliomas\* or brain stem gliomas who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after radiation therapy was completed. (Note: Stratum E is closed to accrual.)
Stratum F: Newly diagnosed high-grade gliomas with metastatic disease within the CNS requiring craniospinal radiation therapy. Patients may or may not have received chemotherapy during radiation, but cannot have received chemotherapy after radiation therapy was completed. (Note: Stratum F is closed to accrual.)
* Eligible histologies include glioblastoma (GBM), anaplastic astrocytoma (AA) or gliosarcoma. Patients…
What they're measuring
1
Safety: Tolerability during the first two vaccine courses as defined in the protocol.