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Status:

TERMINATED

Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain Tumors

Central Nervous System Tumors

Eligibility:

All Genders

3-21 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating fa...

Detailed Description

OBJECTIVES: Primary * Determine the feasibility of escalating the dose of topotecan when administered with filgrastim (G-CSF) and radiotherapy, in terms of increasing the topotecan dose 25-50% above...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of intrinsic pontine brain stem glioma within the past 30 days
  • Histologic confirmation not required provided the tumor has a pontine epicenter AND exhibits diffuse (rather than focal) involvement of ≥ 2/3 of the pons with or without extension to the adjacent medulla or midbrain\* NOTE: \*Brain stem tumors that do not meet these criteria must be histologically confirmed as grade III or IV malignant glioma
  • Measurable disease by radiographic imaging
  • Post-operative MRI required within the past 30 days if patient had a biopsy or surgical resection
  • No disseminated disease
  • No neurofibromatosis type 1
  • PATIENT CHARACTERISTICS:
  • Age
  • 3 to 21 at diagnosis
  • Performance status
  • Lansky 50-100% OR
  • Karnofsky 50-100%
  • Life expectancy
  • At least 8 weeks
  • 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)
  • ALT \< 2.5 times ULN
  • Renal
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
  • Creatinine based on age as follows:
  • No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
  • No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
  • No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
  • No greater than 1.5 mg/dL (for patients over 15 years of age)
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not severely somnolent or comatose
  • Central cortical neurotoxicity scale \< grade 3
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunomodulating agents
  • Chemotherapy
  • No other concurrent anticancer chemotherapy
  • Endocrine therapy
  • Concurrent corticosteroids allowed for neurological deficits related to the tumor
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • See Disease Characteristics
  • Prior biopsy or surgical resection for malignant brain stem glioma allowed
  • Other
  • No other prior therapy for malignant brain stem glioma

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    7 Patients enrolled

    Trial Details

    Trial ID

    NCT00107471

    Start Date

    October 1 2005

    Last Update

    December 10 2013

    Active Locations (80)

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    Page 1 of 20 (80 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, 90242-2814