Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

OBJECTIVES: - 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.


DISEASE CHARACTERISTICS: - Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm^3 AND evidence of blast cells on cytospin preparation or by cytology OR - Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan - Meningeal malignancy must be progressive or refractory to conventional therapy - Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy - No concurrent bone marrow relapse in leukemia or lymphoma patients - 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 - Patients demonstrating restored flow after focal radiotherapy are allowed PATIENT CHARACTERISTICS: Age: - Over 3 Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Not specified Hepatic: - No clinically significant liver function abnormalities Renal: - No clinically significant renal function abnormalities Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus) - No significant systemic illness (e.g., infection) PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy Chemotherapy: - At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered - Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions: - No phase I agent - No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m^2), high-dose cytarabine (more than 2 g/m^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa) - No agent known to have serious unpredictable CNS side effects Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy - At least 8 weeks since prior craniospinal irradiation - Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy - No concurrent whole brain or craniospinal irradiation - Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed - Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances Surgery: - Not specified Other: - At least 1 week since any prior CNS therapy - At least 7 days since prior intrathecal investigational agent - At least 14 days since prior systemic investigational agent - No other concurrent intrathecal or systemic investigational agent - No other concurrent intrathecal or systemic therapy to treat meningeal malignancy - No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier - No concurrent agent known to have serious unpredictable CNS side effects



Primary Contact:

Study Chair
Susan M. Blaney, MD
Texas Children's Cancer Center

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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