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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006024 |
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: lomustine Drug: temozolomide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas |
| Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of temozolomide.
Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment continues every 28 days, if blood counts have recovered, for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5 weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses beginning 4 weeks after completion of radiotherapy.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade malignant glioma of one of the following subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 235 Study Locations| Study Chair: | Regina Jakacki, MD | Children's Hospital of Pittsburgh |
More Information
| Study ID Numbers: | CDR0000068036, COG-ADVL0011, CCG-ADVL0011, CCG-A0993 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006024 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood high-grade cerebral astrocytoma |
|
Astrocytoma Lomustine Antineoplastic Agents, Alkylating Glioma |
Central Nervous System Neoplasms Alkylating Agents Temozolomide Nervous System Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Lomustine Central Nervous System Neoplasms Temozolomide Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |