Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1999-12-02
2001-06-26
Goldberg, Jerome D. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
active
06251886
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods of using microcrystalline compositions of temozolomide in the treatment of cancers, especially in the treatment of neoplastic meningitis and other cancers occurring in compartmentalized regions of the body such as the subarachnoid space.
BACKGROUND
First recognized in 1870 (Eberth, C. J.,
Arch. Pathol. Anat. Physiol. Klin. Med.,
49:51-63 (1870.), neoplastic meningitis is now being seen with increasing frequency, no doubt reflecting more effective therapy of systemic cancer as well as heightened awareness and improvements in diagnostic tools. Neoplastic meningitis can result from leptomeningeal dissemination of a spectrum of cancers, either arising from the central nervous system, such as medulloblastoma or high grade glioma, or resulting from invasion by lymphoma, leukemia, melanoma, sarcoma, or carcinoma (notably breast and lung carcinoma). Furthermore, the striking incidence in AIDS-related CNS lymphoma (which has a 50% incidence of leptomeningeal spread) suggests that an extensive population in the United States and abroad will require treatment of neoplastic meningitis. Unfortunately, current therapy of leptomeningeal disease is particularly ineffective with external beam radiotherapy and intrathecal chemotherapy, specifically methotrexate, thiotepa, or cytosine arabinoside only providing modest benefits, with mean survival following leptomeningeal tumor spread measured in months (Grossman S. A. and Moynihan T. J.,
Neurol. Clin.,
9:843-856, 1991 1991). Newer therapies are clearly needed for treatment of patients with cancer, especially patients with neoplastic meningitis and other cancers occurring in compartmentalized regions of the body.
SUMMARY OF THE INVENTION
The present invention provides methods of using microcrystalline compositions of temozolomide to treat cancer, especially neoplastic meningitis and other cancers occurring in compartmentalized regions of the body such as the subarachnoid space. In particular, the present invention provides a method for treating cancer in a patient in need of such treatment comprising administering temozolomide in an amount sufficient to achieve a clinical response, wherein the temozolomide is administered in a microcrystalline suspension.
Microcrystalline compositions in accordance with the present invention can be used to treat a variety of cancers in the human body, especially by means of regional temozolomide chemotherapy. In particular, methods are provided for treating tumors which can grow and metastisize within cavities of the human body, such as the peritoneum, central nervous system, the lungs, etc.
Microcrystalline compositions of temozolomide in accordance with the present invention can be administered by any number of means, including, e.g., intrathecally, intraventricularly, intraperitoneally, intrapleurally, intravenously, or by administration into an artery that supplies blood to a region of the body, e.g., intrahepatic artery administation to reach the liver, or delivery into the carotid artery system to reach the brain. In a preferred embodiment, microcrystalline suspensions of temozolomide can be administered intrathecally to the subarachnoid space, and the intrathecal administration can be intralumbar or intraventricular (via the Ommaya reservoir). Methods of delivering microcrystalline compositions of temozolomide intraarterially are also provided by the present invention, as are methods of administering such compositions directly into a tumor mass.
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Goldberg Jerome D.
Gould James M.
Kutzenco Allan N.
Schering Corporation
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