Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor.

PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Etoposide phosphate; Lenograstim; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary CNS pure germ cell tumor

• Diagnosed within the past 31 days

• Meets any 1 OR none (i.e., M0 [localized disease]) of the following staging criteria:

• M+ (disseminated disease)

• Leptomeningeal or intraventricular metastases visualized on MRI scans of the brain and spine

• Clumps of tumor cells on lumbar cerebrospinal fluid (CSF) cytology

• Visible tumor studding the walls of the lateral or third ventricles noted during endoscopy or surgery

• Primary tumor arising within the parenchyma of the brain, brainstem, or spinal cord

• Measurable multi-focal tumors arising in both the pineal and suprasellar regions (i.e., multiple midline tumors)

• Infiltrative, intra-axial extension on brain MRI > 1 cm beyond enhancing tumor

• Modified M+ (occult multi-focal disease)

• M0 at diagnosis with a localized pineal region tumor with signs and symptoms of diabetes insipidus without measurable disease in the suprasellar region

• Lumbar CSF assay meeting criteria for the following marker profiles:

• Serum and CSF beta human chorionic gonadotropin (β-HCG) ≤ 50 IU/dL

• Serum alpha fetoprotein (AFP) ≤ 10 IU/L AND ≤ institutional norm

• CSF AFP ≤ 2.0 IU/L AND ≤ institutional norm

PATIENT CHARACTERISTICS:

Age

• 3 to 25

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3 (transfusion independent)

• Hemoglobin > 10.0 g/dL (transfusion allowed)

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 times ULN

Renal

• Creatinine adjusted according to age as follows*:

• No greater than 0.4 mg/dL (≤ 5 months)

• No greater than 0.5 mg/dL (6 months -11 months)

• No greater than 0.6 mg/dL (1 year-23 months)

• No greater than 0.8 mg/dL (2 years-5 years)

• No greater than 1.0 mg/dL (6 years-9 years)

• No greater than 1.2 mg/dL (10 years-12 years)

• No greater than 1.4 mg/dL (13 years and over [female])

• No greater than 1.5 mg/dL (13 years to 15 years [male])

• No greater than 1.7 mg/dL (16 years and over [male]) AND

• Creatinine clearance OR radioisotope glomerular filtration rate > 70 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Euthyroid (with or without levothyroxine sodium therapy) as determined by normal T4 ± thyroid-stimulating hormone levels*

• Diabetes insipidus allowed provided patient is relatively stable on desmopressin acetate

• Normal endogenous cortisol function*

• Adequate antidiuretic hormone reserves* NOTE: *Unless receiving replacement therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Concurrent replacement hormones allowed (e.g., corticosteroids, levothyroxine sodium, and desmopressin acetate)

Radiotherapy

• Not specified

Surgery

• Prior surgery for germ cell tumor allowed

Other

• No other prior therapy for germ cell tumor

• Concurrent anticonvulsants allowed