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

NCT ID: NCT00005955

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2002-09-30

Brief Summary

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.

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.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

temozolomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Duke UMC

Principal Investigators

Henry S. Friedman, MD

Role: STUDY_CHAIR

Duke University

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DUMC-0931-02-6R3

Identifier Type: -

Identifier Source: secondary_id

DUMC-000931-00-5R1

Identifier Type: -

Identifier Source: secondary_id

DUMC-0831-99-5

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1799

Identifier Type: -

Identifier Source: secondary_id

DUMC-000931-01-6R1

Identifier Type: -

Identifier Source: secondary_id

CDR0000067936

Identifier Type: OTHER

Identifier Source: secondary_id

0931

Identifier Type: -

Identifier Source: org_study_id