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ACNS1123 Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Johns Hopkins Kimmel Cancer Center in Baltimore
This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
Ages Eligible for Study: 3 Years to 21 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Patients must be newly diagnosed with localized primary CNS nongerminomatous 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 hCGÎ² greater than 100 mIU/mL or any elevation of serum and CSF alpha-fetoprotein (AFP) greater than 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 hCGÎ² 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 hCGÎ² 5 to â?¤ 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 hCGÎ² â?¤ 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 hCGÎ² â?¤ 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 PATIENT CHARACTERISTICS: Peripheral absolute neutrophil count (ANC) â?¥ 1,000/Î¼L Platelet count â?¥ 100,000/Î¼L (transfusion independent) Hemoglobin â?¥ 8.0 g/dL (may receive red blood cell [RBC] transfusions) Creatinine clearance or radioisotope GFR â?¥ 70 mL/min/1.73 mÂ² OR serum creatinine based on age/gender as follows: 0.4 mg/dL ( 1 month to less than 6 months of age) 0.5 mg/dL (6 months to less than 1 year of age) 0.6 mg/dL (1 to less than 2 years of age) 0.8 mg/dL (2 to less than 6 years of age) 1.0 mg/dL (6 to less than 10 years of age) 1.2 mg/dL (10 to less than 13 years of age) 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to less than 16 years of age) 1.7 mg/dL (male) and 1.4 mg/dL (female) (â?¥ 16 years of age) Total bilirubin â?¤ 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]) less than 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 PRIOR CONCURRENT THERAPY: 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
This is a multicenter study. Patients are stratified according to localized primary disease (nongerminomatous germ cell tumor [NGGCT] vs germinoma). Stratum 1 (NGGCT): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 1 hour and etoposide over 1-2 hours on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease (complete [CR] or partial response [PR]) to induction chemotherapy undergo radiotherapy once daily (QD) 5 days a week for 6 weeks. Patients with PR, stable disease (SD), or progressive disease (PD) and normalization of tumor levels undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo radiotherapy. Stratum 2 (Germinoma): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR undergo radiotherapy QD 5 days a week for approximately 4 weeks. Patients with PR, SD, or PD with normal tumor markers may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor during surgery undergo radiotherapy. Patients with PR or SD with residual disease (â?¤ 1.5 cm) and suprasellar ( greater than 0.5 cm) or pineal ( greater than 1 cm) involvement and normal tumor markers undergo radiotherapy after chemotherapy without second-look surgery. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, and then annually for up to 3 years.
09/29/2016 05:03 AM