Clinical Trial Details
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NCT02358187 : A Vaccine Trial for Low Grade Gliomas
PhasePhase 2
AgesMin: 12 Months Max: 21 Years
Inclusion Criteria:

Tumor Type

- Unresectable low-grade gliomas that have received at least two chemotherapy/biologic
regimens. Radiation therapy counts as a biologic regimen. Patients may not have
received radiation therapy to the index lesion within 1 year of enrollment. Patients
may have tumor spread within the CNS.

- HLA-A2 positive based on flow cytometry.

- 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

- Patients must be = 12 months and < 22 years of age at the time of HLA-A2 screening.

- Patients must have a performance status of = 70; (Karnofsky if > 16 years and Lansky
if = 16 years of age.

- Documented negative serum beta-HCG for female patients who are post-menarchal. Because
the effect of the peptide-based vaccine and poly-ICLC on the fetus has not
sufficiently been investigated, pregnant females will not be included in the study.

- Patients must be free of systemic infection requiring IV antibiotics at the time of
registration. Patients must be off IV antibiotics for at least 7 days prior to

- Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µ;
Platelets > 100,000/µ (transfusion independent); absolute lymphocyte count of = 500/µ;
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 must have recovered from the toxic effects of prior therapy to grade 1 or
better. Patients must be at least 3 weeks from 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.

- Patients may not have received radiation to the index lesion within 1 year of

- 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
requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with
visceral involvement.

- Use of immunosuppressives within four weeks prior to study entry or anticipated use of
immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used
in the peri-operative period must be tapered to 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.

- Because patients with immune deficiency are not expected to respond to this therapy,
HIV-positive patients are excluded from the study.

- Patients who have received prior immunotherapy.
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