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The purpose of this letter is to inform you of a promising new experimental therapeutic option for patients with malignant pleural mesothelioma. This study is sponsored by the FDA Orphan Drug Program and is being conducted at New York University Kaplan Cancer Center. Malignant pleural mesothelioma affects about 3,000 Americans each year. As you know, there is no curative therapy for most patients with this disease. However, our results to date suggest that patients may benefit from this new treatment.
The investigational agent is a liposomal formulation of a highly lipophilic platinum compound known as L-NDDP. It is administered intrapleurally and cleared very slowly from the pleural cavity, thus providing a very favorable depot effect. Moreover, its lipophilicity and creamy nature enhances its local tumor penetration. The dose currently used (450 mg/m2), produces negligible local and systemic toxicities. The initial Phase I study included 21 patients with malignant pleural effusions of various etiologies. Five had mesothelioma. Two out of these 5 failed systemic chemotherapy; however are alive at +5 years after treatment with L-NDDP (Clin. Cancer Res. 3:373-379, 1997). The current Phase II study has enrolled 20 patients; 61% have had a documented pathologic complete remission on second thoracoscopy (Perez-Soler et al., Proceed ASCO 18(1626):421a, 1999). Patients who have received previous chemotherapy are eligible if they have a free-flowing pleural effusion. Based on the known pharmacology of L-NDDP, patients with low burden of disease (tumor thickness less than 1 cm) appear to be the sub-set that may derive the highest benefit from this protocol. For further information or to refer a patient, call (212) 263-8043 or (212) 263-6485.
Sincerely yours,
Roman Perez-Soler, MD
Professor of Medicine
Associate Director of Clinical Oncology
and Translational Research