Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01130077 : A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas
PhaseN/A
AgesMin: 12 Months Max: 21 Years
Eligibility
**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 with any oligodendroglioma component are NOT eligible.

- HLA-A2 positive based on flow cytometry.

- Patients in Stratum A B and E must have received standard involved field radiation
therapy [RT] defined as fractionated external beam radiotherapy with total doses
between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks
of completing RT.

- Patients in Stratum F must have received craniospinal radiation.

- Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day,
max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study
registration.

- All patients must sign an IRB-approved informed consent document

- Patients must be = 12 months and <22 years of age at the time of study registration.

- Patients must have a performance status of = to 60.

- Patients must have life expectancy of at least 8 weeks.

- Documented negative serum ßHCG for female patients who are post-menarchal. Pregnant
females will not be included in the study. Males and females must agree to use
effective birth control methods during the course of vaccination.

- Patients must be free of systemic infection.

- Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µl;
Platelets > 100,000/µl (transfusion independent); absolute lymphocyte count of
=500/uL; Hemoglobin >8 g/dl (may be transfused). Hepatic: bilirubin = 1.5x
institutional normal for age; SGPT (ALT) < 3x institutional normal.

Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR >70
ml/min/ml/min/1.73 m²

- Patients on Strata C and D must have recovered from the toxic effects of prior
therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or
myelosuppressive biological therapy and at least 1 week from the last dose of
non-myelosuppressive biologic therapy.

- No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

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:

- Interferon (e.g. Intron-A®)

- Allergy desensitization injections

- Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)

- Interleukins (e.g. Proleukin®)

- Any investigational therapeutic medication

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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