Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
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|ClinicalTrials.gov Identifier: NCT00100802|
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : January 13, 2017
Last Update Posted : August 7, 2019
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Central Nervous System Tumors||Drug: lomustine Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomustine with historical controls.
- Determine the toxicity of this regimen in these patients.
- Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with this regimen.
- Correlate polymorphisms in GSTP1, GSTM1, and GSTT1 genes and GSTP1 protein expression in tumors with survival in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Chemoradiotherapy: Patients receive oral temozolomide once daily on days 1-42. Patients also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients who did not undergo prior gross total resection also undergo boost radiotherapy once daily on days 43-47.
- Maintenance chemotherapy: Four weeks after completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study within 1-1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||September 1, 2012|
|Actual Study Completion Date :||June 30, 2017|
Experimental: Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.
Procedure: adjuvant therapy
Radiation: radiation therapy
- One Year Overall Survival [ Time Frame: One year ]Estimated one year survival using the Kaplan-Meier methodology.
- Occurrence of Death Attributable to Complications of Protocol Therapy [ Time Frame: While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy ]Number of deaths due to complications of protocol therapy.
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): NCT00100802
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|Study Chair:||Regina Jakacki, MD||University of Pittsburgh|