Poly ICLC in Treating Younger Patients With Recurrent or Progressive Low Grade Gliomas

Inclusion Criteria

• Subjects must have pathologically confirmed low grade glioma with histologic subtypes interpreted as World Health Organization (WHO) grade I and II including: * Juvenile pilocytic astrocytoma (JPA) * Pleomorphic JPA * Diffuse astrocytoma (fibrillary, gemistocytic, giant cell, or pleomorphic xanthoastrocytoma) * Subependymal giant cell astrocytoma (SEGA) * Low grade oligoastrocytoma * Low grade oligodendroglioma * Pilomyxoid astrocytoma * Low grade glioma not otherwise specified (NOS)
• Tumors of all regions of the CNS, with appropriate histology are eligible for study; however patients with SEGA or tumors intrinsic to the optic nerve and involvement of the optic nerve that cannot be biopsied/resected are eligible without histological confirmation
• Subjects with neurofibromatosis type 1 (NF1) are also eligible
• All pathologic diagnoses of subjects from all enrolling sites will be confirmed with tissue block review of previously obtained specimens by Scott VandenBerg, M.D., Ph.D; this will be done in order to assure uniformity in the above subtypes for these sometimes difficult to diagnose tumors; once consent is obtained, subjects’ tissue/slides and corresponding pathology report should be forwarded for central review at University of California at San Diego (UCSD)
• Subjects must have demonstrated either tumor progression or recurrence by any of the radiographic criteria and/or clinical criteria as defined below: * Subjects with progressive non-resectable disease regardless of location in the brain or spine are eligible for this study; patients with evidence of leptomeningeal dissemination are eligible for this study; patients do not require biopsy/histologic confirmation at the time of progression or relapse * Radiographic progression is defined as > 40% increase in the product of the three perpendicular diameters of current tumor relative to the baseline measurement (defined as either the initial scan or scan at start of a previous therapy): length (L) x width (W) x transverse (T) (current scan) > 1.4 x L x W x T (baseline scan), or the development of any new sites of disease independent of the response of the initial tumor * Post radiation changes are often seen on post-treatment imaging studies, so that classification of a patient as having progressive disease may require several serial magnetic resonance imaging (MRI)’s if the child has received radiation within the preceding 12 months * Tumor volume includes the entire tumor volume seen on gadolinium enhanced T1 magnetic resonance (MR) imaging plus non-enhancing abnormality seen on T2 or fluid attenuated inversion recovery (FLAIR); coronal and axial images will be evaluated * All tumor cysts will be included in the tumor volume * Clinical progression without radiographic progression includes children with optic pathway gliomas who demonstrate sustained decrease in visual fields and/or acuity in three serial vision examinations; each of the vision examinations must be performed > 2 weeks apart * Children with previously negative cerebrospinal fluid (CSF) cytology who show evidence of tumor cells in fluid obtained by lumbar puncture can be designated as having progressive disease in the absence of radiographic evidence of progression
• Subjects must have a performance status of > 50%; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Subjects must have a life expectancy of >= 8 weeks
• Subjects must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below: * Myelosuppressive chemotherapy: Subjects must have received the last dose of myelosuppressive therapy at least 3 weeks prior to study registration or at least 6 weeks if therapy included nitrosourea * Investigational/biological agent: Subjects must have received the last dose of other investigational or biological agent > 7 days prior to study registration; subjects must not have received poly-ICLC in the past * Radiation therapy (XRT): Subjects must be >= 8 weeks since the completion of radiation therapy * Study specific limitations on prior therapy: There is no limit on the number of prior treatment regimens or received doses of radiation therapy * Growth factor(s): Subjects must not have received any hematopoietic growth factors within 7 days of study entry or 21 days for pegfilgrastim * Prior surgery: Subjects must be >= 2 weeks from prior surgery * Steroids: Subjects must be on a stable steroid dose for 7 days prior to study entry if they are on steroid treatment
• Hemoglobin: >= 8.0 gm/dl (may transfuse peripheral red blood cells [PRBCs])
• Absolute neutrophil count (ANC): >= 750/mm^3, must be at least 7days after last dose of growth factor
• Platelet count: >= 50,000 (transfusion independent; >= 7 days from last transfusion)
• Creatinine clearance/glomerular filtration rate (GFR) > 70 cc/min/1.73 m^2 or serum creatinine based on age/gender as follows: * 1 month to < 6 months: 0.4 mg/dL * 6 months to < 1 year: 0.5 mg/dL * 1 to < 2 years: 0.6 mg/dL * 6 to < 10 years: 0.8 mg/dL * 10 to < 13 years: 1 mg/dL * 13 to < 16 years: 1.5 (male), 1.4 (female) * >= 16 years: 1.7 (male), 1.4 (female)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 2.5 x ULN
• No evidence of dyspnea at rest
• No exercise intolerance
• Pulse oximetry >= 94% if there is clinical indication for determination
• Normal prothrombin time (PT)
• Partial thromboplastin time (PTT) at enrollment per institutional range
• Negative serum beta-human chorionic gonadotropin (HCG) in females, and agreement to the use of effective contraception in males and females of childbearing potential, IS REQUIRED

Exclusion Criteria

• Pregnant or lactating females; women of childbearing age will agree to use contraception during the protocol
• Patients receiving other experimental immunotherapy
• Patients may not have fever (38.5*C) within 7 days of enrollment
• No concurrent XRT or chemotherapy is allowed
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study