Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Status: Recruiting
Phase: Phase 2
Diagnosis: Pediatric Oncology, Pediatric Brain Tumor
NCT ID: NCT01602666
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-389
RATIONALE: Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: 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.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI:
Susan Chi, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
David Ebb, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility 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 hCGβ > 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 hCGβ 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 hCGβ 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 hCGβ ≤ 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 hCGβ ≤ 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) ≥ 1,000/μL
- Platelet count ≥ 100,000/μL (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
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