Drug – bio-affecting and body treating compositions – Lymphokine – Interferon
Reexamination Certificate
2001-07-09
2003-08-12
Eyler, Yvonne (Department: 1646)
Drug, bio-affecting and body treating compositions
Lymphokine
Interferon
C424S085100, C424S085400, C530S351000, C530S421000, C514S002600
Reexamination Certificate
active
06605273
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to an improved therapy for treating patients having renal cell carcinoma (“RCC”) by administering a therapeutically effective dose of pegylated interferon-alpha for a time sufficient to achieve at least a partial tumor response.
Metastatic renal cell carcinomas are generally resistant to chemotherapy, either with single agents or in combination. Greater success has been seen with immunotherapy, particularly with the use of interleukin-2 (“IL-2”). Therapy with high dose intravenous IL-2 has resulted in objective tumor responses in approximately 14% of patients, some with long durability. The administration of high dose IL-2 is associated with capillary leak syndrome, which results in hypotension and reduced organ perfusion which can be severe and sometimes fatal. These toxicities have generally inhibited the use of IL-2 to a highly selected group of patients administered by physicians with significant experienced in its administration. The use of lower-dose and subcutaneously (SC) administered regimens of IL-2 alone or in combination with other biologic agents, including interferon-&agr;, has been explored in an effort to develop a more broadly applicable therapy for this disease. For example, Atzpodien, J., et al. disclosed in J. Clin Oncol., 1995, Volume 13, pages 497-501 that the combination treatment of subcutaneous (“SC”) administration and lower dose regimens of interferon alpha-2b and SC interleukin-2 to patients with progressive metastatic RCC produced tumor response with lower toxicity. It must be noted that the response rates are low and that injections of interferon alpha-2b 5 million IU/m
2,
three times a week (“TIW”), were required to achieve these results. In addition, interferon alpha-2b has many side effects that a substantial number of patients find unacceptable, and patient compliance with the TIW injections of interferon alpha-2b has become a problem. Accordingly, there is a need for an improved therapy for treating patients having RCC.
SUMMARY OF THE INVENTION
The present invention provides a method of treating a patient having renal cell carcinoma which comprises administering to such a patient a therapeutically effective dose of pegylated interferon alpha for a time period sufficient to effect at least a partial tumor response.
The present invention also provides a method of treating a patient having metastatic renal cell carcinoma which comprises administering to said patient an effective amount of pegylated interferon-alpha once a week for a time period sufficient to effect at least a partial tumor response.
The present invention further provides a method of treating a patient having metastatic renal cell carcinoma which comprises administering to such a patient about 4.5 micrograms/kg to about 9.0 micrograms/kg of pegylated interferon alpha-2b once a week for a time period sufficient to effect at least a partial tumor response.
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Rose Esther Helen
Ryback Mary Ellen
Andres Janet L.
Eyler Yvonne
Schering Corporation
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