Phase I Study of Intrathecal Mafosfamide

Summary

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).

Timeline

Start

1989-11

Primary completion

—

Completion

2003-11

Publications

• Background Atassi G, Hilgard P, Pohl J. Antineoplastic activity of ASTA Z 7557 (NSC-345842, INN mafosfamide) on transplantable murine tumors. Invest New Drugs. 1984;2(2):169-73. doi: 10.1007/BF00232347.
• Background Bruntsch U, Groos G, Hiller TA, Wandt H, Tigges FJ, Gallmeier WM. Phase-I study of mafosfamide-cyclohexylamine (ASTA-Z-7557, NSC 345 842) and limited phase-I data on mafosfamide-lysine. Invest New Drugs. 1985;3(3):293-6. doi: 10.1007/BF00179434.
• Background Arndt CA, Colvin OM, Balis FM, Lester CM, Johnson G, Poplack DG. Intrathecal administration of 4-hydroperoxycyclophosphamide in rhesus monkeys. Cancer Res. 1987 Nov 15;47(22):5932-4.

Drugs

Indications