Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
|ClinicalTrials.gov Identifier: NCT00006246|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 7, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this treatment regimen.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Leukemia Lymphoma Metastatic Cancer Retinoblastoma Sarcoma||Drug: busulfan||Phase 1|
- Determine the qualitative and quantitative toxicities of intrathecally administered busulfan in children and adolescents with refractory CNS malignancies.
- Determine the maximum tolerated dose of this treatment regimen in these patients.
- Determine the cerebrospinal fluid and serum pharmacokinetics of this treatment regimen in these patients.
- Determine the efficacy of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive intrathecal busulfan twice a week, at least 3 days apart, for 2 weeks. Patients with complete or partial response or stable disease may continue therapy once a week for 2 weeks, once a week every other week for 2 treatments, and then once a month thereafter in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of busulfan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for the first year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study over 18-38 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Official Title:||Phase I Study of Intrathecal Spartaject-Busulfan in Children With Neoplastic Meningitis|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||May 2003|
- Toxicities of IT administered busulfan in children and adolescents with refractory CNS malignancies
- Maximum tolerated dose of IT administered busulfan
- Serum and CSF pharmacokinetics of IT administered busulfan
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006246
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Sri Gururangan, MD||Duke University|