Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Enrollment: | 53 |
| Study Start Date: | March 1999 |
| Study Completion Date: | April 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
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:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic pleomorphic xanthoastrocytoma
- Anaplastic or malignant oligoastrocytoma
- Gemistocytic astrocytoma
- Malignant glioma
- Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement)
- Diffuse pontine gliomas with greater than 2/3 involvement of the pon
PATIENT CHARACTERISTICS:
Age:
- 3 to 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 2,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT less than 5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior corticosteroids allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- No more than 28 days since prior definitive surgery for brain tumor
Other:
- Concurrent anticonvulsants allowed
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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004068 History of Changes |
| Other Study ID Numbers: | CDR0000067271, P30CA021765, SJCRH: SJHG98, SPRI-P-00112, NCI-G99-1577 |
| Study First Received: | December 10, 1999 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by St. Jude Children's Research Hospital:
|
childhood high-grade cerebral astrocytoma childhood high-grade cerebellar astrocytoma childhood oligodendroglioma untreated childhood brain stem glioma untreated childhood cerebellar astrocytoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Temozolomide Dacarbazine Irinotecan Camptothecin Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013