Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
NCT ID: NCT00004068
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
1999-03-31
2003-04-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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irinotecan hydrochloride
temozolomide
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Principal Investigators
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Amar Gajjar, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Broniscer A, Chintagumpala M, Fouladi M, Krasin MJ, Kocak M, Bowers DC, Iacono LC, Merchant TE, Stewart CF, Houghton PJ, Kun LE, Ledet D, Gajjar A. Temozolomide after radiotherapy for newly diagnosed high-grade glioma and unfavorable low-grade glioma in children. J Neurooncol. 2006 Feb;76(3):313-9. doi: 10.1007/s11060-005-7409-5.
Broniscer A, Iacono L, Chintagumpala M, Fouladi M, Wallace D, Bowers DC, Stewart C, Krasin MJ, Gajjar A. Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98). Cancer. 2005 Jan 1;103(1):133-9. doi: 10.1002/cncr.20741.
Broniscer A, Chintagumpala M, Bowers D, et al.: Upfront protracted irinotecan (CPT-11) followed by radiotherapy (RT) and temozolomide (TMZ) in the treatment of children with newly diagnosed high-grade glioma (HGG) and unfavorable low-grade glioma (LGG): results of a multi-institutional study (SJHG-98). [Abstract] Neuro-Oncology 6 (4): TP-01, 385, 2004.
Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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SJCRH: SJHG98
Identifier Type: -
Identifier Source: secondary_id
SPRI-P-00112
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1577
Identifier Type: -
Identifier Source: secondary_id
CDR0000067271
Identifier Type: -
Identifier Source: org_study_id