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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain Tumor

Central Nervous System Tumor

Eligibility:

All Genders

3-25 years

Phase:

PHASE3

Brief 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 y...

Detailed Description

OBJECTIVES: Primary * Compare event-free survival and overall survival of patients with newly diagnosed primary CNS germ cell tumor treated with conventional radiotherapy alone (regimen A) vs chemot...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2009

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00085098

    Start Date

    January 1 2007

    End Date

    May 1 2009

    Last Update

    September 7 2018

    Active Locations (107)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 27 (107 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Phoenix Children's Hospital

    Phoenix, Arizona, United States, 85016-7710

    3

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    4

    Southern California Permanente Medical Group

    Downey, California, United States, 90027