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.]

NCT01602666 : Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
PhasePhase 2
AgesMin: 3 Years Max: 21 Years
Eligibility
Inclusion Criteria:

- Patients must be newly diagnosed with localized primary CNS non germinomatous germ
cell tumor (NGGCT) (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ
cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal +suprasellar),
and ventricles are eligible; tumors present in the above mentioned locations and with
unifocal parenchymal extension are eligible

- Stratum 1( NGGCT): Patients must have one of the following criteria:

- Patients with serum and/or CSF hCG? > 100 mIU/mL or any elevation of serum
and CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the
institutional normal are eligible, irrespective of biopsy results

- Patients with any of the following elements on biopsy/resection are
eligible, irrespective of serum and/or CSF hCG? and AFP levels: endodermal
sinus tumor (yolk sac),embryonal carcinoma, choriocarcinoma,
malignant/immature teratoma, and mixed GCT with malignant GCT elements

- Stratum 2 (Germinoma): Patients must have one of the following criteria:

- Patients with institutional normal AFP AND hCG? 5 to ? 50 mIU/mL in serum
and/or CSF are eligible; no histologic confirmation required

- Patients with bifocal (pineal + suprasellar) involvement or pineal lesion
with diabetes insipidus AND hCG? ? 100 mIU/mL and institutional normal AFP
in serum and/or CSF are eligible; no histologic confirmation required

- Patients with histologically confirmed germinoma or germinoma mixed with
mature teratoma and hCG? ? 100 mIU/mL and institutional normal AFP in serum
and/or CSF are eligible

- Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless
medically contraindicated

- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123

- Patients with mature teratoma with normal tumor markers are not eligible

- Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not
eligible

- Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are
not eligible

- Peripheral absolute neutrophil count (ANC) ? 1,000/?L

- Platelet count ? 100,000/?L (transfusion independent)

- Hemoglobin ? 8.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope GFR ? 70 mL/min/1.73 m² OR serum creatinine
based on age/gender as follows:

- 0.4 mg/dL ( 1 month to < 6 months of age)

- 0.5 mg/dL (6 months to < 1 year of age)

- 0.6 mg/dL (1 to < 2 years of age)

- 0.8 mg/dL (2 to < 6 years of age)

- 1.0 mg/dL (6 to < 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) and 1.4 mg/dL (female) (? 16 years of age)

- Total bilirubin ? 1.5 times upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) < 2.5
times ULN

- Patients with seizure disorder may be enrolled if well controlled

- Patients must not be in status, coma, or assisted ventilation prior to study
enrollment

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative
pregnancy test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation

- Patients who had more than 1 prior surgery/biopsy are eligible

- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01602666      |      Link to official Clinicaltrials.gov listing
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