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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 4 Years - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00005955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Henry S. Friedman, MD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Neuroblastoma
Additional Details

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.#46;brain stem glioma vs.#46;malignant glioma vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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