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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004068 |
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 chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: irinotecan hydrochloride Drug: temozolomide Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 1999 |
OBJECTIVES:
OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on weeks 1-2. Treatment repeats every 3 weeks for 2 courses.
Following completion of irinotecan and if appropriate, patients may undergo a second surgical resection.
Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second resection, patients receive image guided external beam radiotherapy 5 days per week for 6 weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost radiosurgery.
At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5 days. Treatment repeats every 3 weeks for 6 courses.
Patients are followed every 3 months for 2 years, then every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed brain tumors
Grade III or IV disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Study Chair: | Amar Gajjar, MD | St. Jude Children's Research Hospital |
More Information
| Study ID Numbers: | CDR0000067271, SJCRH-SJHG98, SPRI-P-00112, NCI-G99-1577 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004068 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood high-grade cerebral astrocytoma childhood high-grade cerebellar astrocytoma childhood oligodendroglioma untreated childhood brain stem glioma untreated childhood cerebellar astrocytoma |
|
Astrocytoma Irinotecan Central Nervous System Neoplasms Temozolomide Camptothecin Brain Neoplasms Brain Stem Glioma, Childhood |
Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Antineoplastic Agents, Phytogenic Nervous System Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Irinotecan Enzyme Inhibitors Central Nervous System Neoplasms Temozolomide Camptothecin |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Nervous System Neoplasms |
