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Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00005955
First received: July 5, 2000
Last updated: June 19, 2013
Last verified: October 2009
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neuroblastoma
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Study Start Date: August 2000
Study Completion Date: September 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors.
  • Determine the toxicity of this treatment in these patients.
  • Determine the overall survival in these patients for 18 months following the study after receiving this treatment.

OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other).

Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy.

PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy
  • Patients with diffuse pontine tumors do not require histological confirmation
  • Eligible types include the following:

    • Ependymoma
    • Malignant glioma

      • Anaplastic astrocytoma
      • Glioblastoma multiforme
      • Anaplastic oligodendroglioma
      • Gliosarcoma
      • Anaplastic mixed oligoastrocytoma
    • Brainstem glioma
    • Primitive neuroectodermal tumor
    • Nongerminoma germ cell tumor
  • At least one bidimensionally measurable lesion

    • At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days after surgery
    • Diffuse pontine tumors are not required to be measurable
  • Neurologically stable

PATIENT CHARACTERISTICS:

Age:

  • 4 to 21

Performance status:

  • Karnofsky or Lansky 70-100%

Life expectancy:

  • Greater than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN
  • SGOT and SGPT less than 2.5 times ULN

Renal:

  • BUN and creatinine less than 1.5 times ULN

Other:

  • Must be able to swallow capsules
  • No acute infection treated with intravenous antibiotics
  • No nonmalignant systemic disease that makes patient a poor medical risk
  • No frequent vomiting or medical condition that may interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than one prior biologic therapy regimen
  • No concurrent biologic therapy
  • No concurrent growth factors or epoetin alfa

Chemotherapy:

  • No more than one prior chemotherapy regimen
  • No other concurrent chemotherapy

Endocrine therapy:

  • No increasing doses of steroids within one week of study

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks, but no greater than 4 weeks, since prior surgical resection and recovered

Other:

  • No other concurrent investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005955

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Henry Friedman, MD, Duke UMC
ClinicalTrials.gov Identifier: NCT00005955     History of Changes
Other Study ID Numbers: 0931, DUMC-0931-02-6R3, DUMC-000931-00-5R1, DUMC-0831-99-5, NCI-G00-1799, DUMC-000931-01-6R1, CDR0000067936
Study First Received: July 5, 2000
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
childhood infratentorial ependymoma
childhood low-grade cerebral astrocytoma
childhood supratentorial ependymoma
childhood craniopharyngioma
localized resectable neuroblastoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood cerebellar astrocytoma
untreated childhood medulloblastoma
untreated childhood visual pathway and hypothalamic glioma
newly diagnosed childhood ependymoma
childhood central nervous system choriocarcinoma
childhood central nervous system embryonal tumor
childhood central nervous system mixed germ cell tumor
childhood central nervous system teratoma
childhood central nervous system yolk sac tumor

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neuroblastoma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014