| ID | Type | Description | Link |
|---|---|---|---|
| PRO08030085 | Other Identifier | Former identifier from University of Pittsburgh IRB |
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| Name | Class |
|---|---|
| Ellie Kavalieros Fund | UNKNOWN |
| Translational Brain Tumor Research Fund | UNKNOWN |
| Connor's Cure | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA Restricted glioma antigen peptides plus Poly ICLC | Experimental | All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA-A2 restricted glioma antigen peptides vaccine | Biological | Vaccine given every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Tolerability during the first two vaccine courses as defined in the protocol. | Tolerability during the first two vaccine courses as defined in the protocol. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glioma-associated antigen-specific T-cell response | Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays | Monitoring will continue as long as subject remains on study. |
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**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.)
Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR >70 ml/min/ml/min/1.73 m²
Exclusion Criteria:
Patients living outside of North America are not eligible.
Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.
Patients in Stratum F must have tumor spread within the CNS.
Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.
Concurrent treatment or medications (must be off for at least 1 week) including:
Patients must not have a history of, or currently active autoimmune disorders.
Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.
Patients with known addiction to alcohol or illicit drugs.
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| Name | Affiliation | Role |
|---|---|---|
| James Felker, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24888813 | Derived | Pollack IF, Jakacki RI, Butterfield LH, Hamilton RL, Panigrahy A, Potter DM, Connelly AK, Dibridge SA, Whiteside TL, Okada H. Antigen-specific immune responses and clinical outcome after vaccination with glioma-associated antigen peptides and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in children with newly diagnosed malignant brainstem and nonbrainstem gliomas. J Clin Oncol. 2014 Jul 1;32(19):2050-8. doi: 10.1200/JCO.2013.54.0526. Epub 2014 Jun 2. | |
| 24792486 |
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Pilot study to assess tolerability of this vaccine regimen in different strata of children with high risk gliomas
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| Poly-ICLC | Biological | Vaccine given every 3 weeks |
|
| Derived |
| Robison NJ, Kieran MW. Diffuse intrinsic pontine glioma: a reassessment. J Neurooncol. 2014 Aug;119(1):7-15. doi: 10.1007/s11060-014-1448-8. Epub 2014 May 3. |
| ID | Term |
|---|---|
| C019531 | poly ICLC |
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