Phase 2 N=244 Treatment

Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

Central Nervous System Nongerminomatous Germ Cell Tumor · Childhood Germinoma

Bottom Line

View on ClinicalTrials.gov: NCT01602666 ↗

Enrolled (actual)

244

Serious AEs

2.5%

Results posted

Dec 2020

Primary outcome: Primary: 3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation — 83.33 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 3-Dimensional Conformal Radiation Therapy (Radiation); Carboplatin (Drug); Etoposide (Drug); Ifosfamide (Drug); Intensity-Modulated Radiation Therapy (Radiation)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY 3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation	83.33	—
PRIMARY 3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy	86.49	—
PRIMARY Neurocognitive Function Using the ALTE07C1 Protocol	9.4; 10.0; 10.1; 9.8; 9.3; 10.2	—
SECONDARY Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)	87.88	—
SECONDARY Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed	92.42	—
SECONDARY Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL	93.26; 80.00	—
SECONDARY Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL	98.38; 100	—

Summary

This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). 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, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors 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 hCGbeta > 100 mIU/mL or any elevation of serum and/or 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 hCGbeta 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 both serum and CSF markers obtained (unless obtaining CSF is medically contraindicated) and must have one of the following criteria to be eligible:
Patients with institutional normal AFP (or = = 1,000/uL
Platelet count >= 100,000/uL (transfusion independent)
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:
0.8 mg/dL (2 to = 16 years of age)
Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate 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

Exclusion Criteria

Patients with mature teratoma or completely resected immature 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 cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible
Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
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
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01602666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.