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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031928 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Drug: mafosfamide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Intrathecal Mafosfamide |
| Estimated Enrollment: | 3000 |
| Study Start Date: | January 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meningeal malignancy must be progressive or refractory to conventional therapy
No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions:
Endocrine therapy:
Radiotherapy:
No concurrent whole brain or craniospinal irradiation
Surgery:
Other:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000069240, NCI-90-C-0095K, BCM-H-3241 |
| Study First Received: | March 8, 2002 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031928 History of Changes |
| Health Authority: | United States: Federal Government |
|
leptomeningeal metastases |
|
Meningeal Neoplasms Immunologic Factors Adjuvants, Immunologic Neoplasm Metastasis Mafosfamide |
|
Neoplasms Neoplastic Processes Pathologic Processes Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Neoplasm Metastasis Mafosfamide Pharmacologic Actions |