Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
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|ClinicalTrials.gov Identifier: NCT00031928|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
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 determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: mafosfamide||Phase 1|
- Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3000 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Official Title:||Phase I Study of Intrathecal Mafosfamide|
|Study Start Date :||January 2002|
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): NCT00031928
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|Texas Children's Cancer Center|
|Houston, Texas, United States, 77030-2399|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Vermont|
|Neurological Research Center, Inc.|
|Bennington, Vermont, United States, 05201|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Susan M. Blaney, MD||Texas Children's Cancer Center|