TNP-470, administered as a weekly, 1-hour infusion to patients with early AIDS-KS is well-tolerated at doses up to and including the highest dose tested. Tumor responses were observed in a substantial number of cases and occurred at various dose levels. TNP-470 should be evaluated further in patients with AIDS-KS as a single agent and in combination with other biologic response modifiers in early disease or after initial response to cytotoxic chemotherapy.

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5580 Background: CA4P is the first tubulin-binding vascular disrupting agent tested in the clinic. Phase I studies were devoid of significant myelosuppression, DLT included cardiovascular side effects, and there was demonstrable activity in ATC (Cancer Res 2002; 62:3408; Clin Cancer Res 2004; 10:96). Methods: Patients with metastatic ATC, good performance status, normal ECG and cardiac function, and no prior therapy for disseminated disease were eligible for study. CA4P at a dose of 45 mg/m2 was administered as 10-minute IV infusion on days 1, 8 and 15 every 28 days (1 cycle) until progression of disease. Results: A total of 18 patients (pts) (11M/7F), median age 62 (range 40–71 yrs), received a total of 55.67 cycles of treatment. Therapy was well tolerated with mild to moderate nausea, vomiting, headache, and tumor pain (3 pts with grade 3) all of which essentially resolved within first 24 hrs. There was no clinically meaningful myelosuppression or cardiac toxicity. No objective responses were seen; 6 pts with stable disease and 12 pts progressed. Median progression free survival (PFS) was 7.4 wks (range 2–84+ wks); with 28% of pts progression free > 3.0 mos. (12.0+, 14.3, 15.3, 25.6 and 84.0+ wks). Pts without bulky disease tended to do better. Fourteen pts have died; 4 are alive; and 2 are alive and on-study at 12.0+ and 84.0+ wks. Median survival is on the order of approximately 20 wks. Conclusions: Approximately a quarter of patients treated with single-agent CA4P experience greater than 3 mos. freedom from progression. Combined modality strategies with CA4P and either chemotherapy and other targeted agents or with radiation are warranted. [Supported in part by a clinical grant from OXiGENE, Inc., Waltham, MA and NIH grant nos. M01 RR-00080]. No significant financial relationships to disclose.

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Non-acquired immunodeficiency syndrome (AIDS)-defining neoplasms are being increasingly recognized in patients infected with the human immunodeficiency virus (HIV). The incidence of Hodgkin's disease and seminoma has recently been reported to be increasing in these patients. This article describes the second case of breast cancer in an HIV-infected male patient. A total of 11 cases of coincident breast cancer and HIV infection have previously been reported. It may be prudent to consider breast cancer in the differential diagnosis of an axillary mass in an HIV-infected patient.