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

NCT00005955 | Completed Phase 2

• 7 other identifiers: 0931DUMC-0931-02-6R3DUMC-000931-00-5R1DUMC-0831-99-5NCI-G00-1799DUMC-000931-01-6R1CDR0000067936
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma

Keywords

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

Interventions

temozolomide DRUG

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma; Astrocytoma; Oligodendroglioma; Choroid Plexus Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Henry S. Friedman, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Study Completion: September 1, 2002
• Last Updated: June 20, 2013

Record last verified: 2009-10

Locations

US (1)