Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Mafosfamide

Adjuvants, Immunologic

Immunologic Factors

mafosfamide

Susan M. Blaney, MD

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.

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.

Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors

Phase I Study of Intrathecal Mafosfamide

National Cancer Institute (NCI)

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphosarcoma

Alkylating Agents

The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated derivative of cyclophosphamide against meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal mafosfamide will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal mafosfamide will also be studied.

Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors	NCT00031928	Brain and Centr...	mafosfamide	3 Years -	National Cancer Institute (NCI)
Phase I Study of Intrathecal Mafosfamide	NCT00001251	Leukemia Lymphoma Meningeal Neopl...	Mafosfamide	-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for mafosfamide

Every month we try and update this database with for mafosfamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mafosfamide

Every month we try and update this database with for mafosfamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mafosfamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.