Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

irinotecan hydrochloride

+ temozolomide

+ conventional surgery

DrugProcedureRadiation
Who is being recruted

Glioma+11

+ Neoplasms

+ Neoplasms by Histologic Type

From 3 to 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorSt. Jude Children's Research Hospital
Last updated: October 4, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004068
Principal SponsorSt. Jude Children's Research Hospital
Last updated: October 4, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

GliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialAstrocytomaOligodendrogliomaCentral Nervous System Neoplasms

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Saint Jude Children's Research Hospital

Memphis, United StatesOpen Saint Jude Children's Research Hospital in Google Maps
CompletedOne Study Center