Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
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|ClinicalTrials.gov Identifier: NCT00004068|
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : October 4, 2011
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: irinotecan hydrochloride Drug: temozolomide Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and partial response rate in patients with postoperative measurable disease, and in terms of the rate of freedom from recurrence in patients with no postoperative measurable disease.
- Determine the 3 year overall and progression free survival rates in this patient population when treated with adjuvant irinotecan followed by radiotherapy and temozolomide.
- Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this patient population.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|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|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||April 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004068
|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|