Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors
|ClinicalTrials.gov Identifier: NCT00389584|
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : November 6, 2017
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Adults Long-term Effects Secondary to Cancer Therapy in Children Poor Performance Status Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Procedure: cognitive assessment Procedure: management of therapy complications Radiation: radiation therapy||Phase 1 Phase 2|
- Determine the maximum tolerated dose of irinotecan hydrochloride administered concurrently with whole-brain radiotherapy in patients with brain metastases from solid tumors. (Phase I) (Phase I closed to accrual as of 4/15/05)
- Determine the toxicity of this regimen in these patients. (Phase I) (Phase I closed to accrual as of 4/15/05)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Assess the neurocognitive function of these patients by Mini-Mental Status Examination. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of irinotecan hydrochloride (phase I closed to accrual as of 4/15/05) followed by a phase II study. Patients enrolled in phase II are stratified according to cognitive dysfunction (yes vs no).
- Phase I (closed to accrual as of 4/15/05): Patients undergo whole-brain radiotherapy (WBRT) once daily, 5 days a week, for 3 weeks (15 fractions). Patients also receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, and 15.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II (for patients enrolled after 4/15/05): Patients receive irinotecan hydrochloride at the MTD and undergo concurrent WBRT as in phase I.
Patients complete the Mini-Mental Status Examination to assess neurocognitive function at baseline, on the last day of radiotherapy, and periodically after completion of study therapy.
After completion of study therapy, patients are followed monthly for 3 months, at 6 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Official Title:||Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors|
|Study Start Date :||December 2002|
|Primary Completion Date :||November 2006|
|Study Completion Date :||November 2006|
- Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)
- Overall survival (Phase II)
- Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II)
- Time to cognitive failure as assessed by Kaplan-Meier (Phase II)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389584
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Allan Y. Chen, MD, PhD||University of California, Davis|