Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 5, 2000
June 19, 2013
August 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00005955 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
Drug: temozolomide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2002
Not Provided

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
Both
4 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005955
0931, DUMC-0931-02-6R3, DUMC-000931-00-5R1, DUMC-0831-99-5, NCI-G00-1799, DUMC-000931-01-6R1, CDR0000067936
Not Provided
Henry Friedman, MD, Duke UMC
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
Duke University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP