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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Standard Chemotherapy in Treating Young Patients with Medulloblastoma or Other Central Nervous System Primitive Neuro-ectodermal Tumors

This randomized clinical trial studies how well standard chemotherapy works in treating young patients with medulloblastoma or other central nervous system primitive neuro-ectodermal tumors. Drugs used in standard chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Neuroblastoma (Pediatrics)
Phase IV
Children
Chemotherapy - cytotoxic, Radiotherapy, Supportive Care, Therapy (NOS)
Carboplatin, Cisplatin, Cyclophosphamide (CTX), Etoposide, Filgrastim (GCSF), Leucovorin, Mesna, Methotrexate, Radiation, Vincristine
Esbenshade, Adam
National
Vanderbilt University
06-26-2018
Treatment
VICCPED1751
NCT02875314

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Children with definitive confirmatory eligible histologic or cytological diagnosis of eligible CNS tumor within the brain or spinal cord, who have not previously received either irradiation or chemotherapy (except corticosteroids) will be eligible for study entry

Children who have histologically proven diagnoses of the following types of CNS tumor are eligible for entry onto this protocol; the exclusive focus is on medulloblastoma and other CNS primitive neuro-ectodermal tumors (PNET) of the brain or spinal cord

Medulloblastoma: * Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis * Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis * Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection

All children less than 120 months (10years) of age, irrespective of clinical stage, with a diagnosis of any of the following CNS PNET are eligible: pineoblastoma, all primary CNS-PNET, including CNS/cerebral neuroblastoma, CNS/cerebral ganglioneuroblastoma, medulloepithelioma, ependymoblastoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR; more recently designated as "embryonal tumor with multilayered rosettes" or "ETMR"), melanotic medulloblastoma and/or medullomyoblastoma, CNS supratentorial PNET, spinal cord PNET, brainstem PNET are all eligible, regardless of patterns of (divergent) differentiation

Histologic diagnosis is mandatory for all patients prior to study entry; study eligibility will be based on institutional pathology; however, performance (and ultimate submission for Central Pathology review) of immunohistochemically (IHC) stained slides for INI11 (to rule out CNS AT/RT), GFAP, EMA, neuronal markers (synaptophysin) for all tumors, as well as a reticulin stain for medulloblastomas displaying any degree of desmoplasia on conventional microscopy, is required; in addition, requested, but not required, are IHC slides for P53 and MIB-1/Ki-67 for all tumors

Children must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (magnetic resonance imaging [MRI] of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar cerebrospinal fluid (CSF) cytological examination; the required eligibility observations must be done within 21 days of the start date of treatment; the date protocol therapy is projected to start must be no later than 7 calendar days after the date of study enrollment

Bilirubin less than 1.5 mg/dL (except for patients with Gilbert’s Syndrome of indirect hyperbilirubinemia)

Transaminases (serum glutamic pyruvic transaminase [SGPT] or alanine aminotransferase [ALT], and serum glutamic oxaloacetic transaminase [SGOT] or aspartate aminotransferase [AST]) less than 2.5 (two and a half) times the upper limits of institutional normal

Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m^2 within 21 days of protocol therapy; kidney function cannot be estimated by other means

Adequate Bone Marrow Function defined as: * Peripheral absolute phagocyte count (APC) > 1000/ µL; APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count. * Platelet Count > 100,000/µL (transfusion independent) * Hemoglobin > 8 gm/dL (may have received RBC transfusions)



Exclusion Criteria:

All diagnoses other than medulloblastoma and CNS PNET - these include: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord.; All choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)

Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.

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