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Results of a Randomized Study of IM862 Nasal Solution in the Treatment of AIDS-Related Kaposi’s Sarcoma

From the Department of Medicine, Division of Hematology, Kenneth Norris Cancer Hospital and Research Institute, University of Southern California School of Medicine, Los Angeles, CA; and Department of Medicine, Division of Hematology, Massachusetts General Hospital, Harvard Medical Center, Boston, MA.

Address reprint requests to Parkash S. Gill, MD, Norris Cancer Hospital and Research Institute, 1441 Eastlake Ave, MS-34, Los Angeles, CA 90033; email parkashg{at}hsc.usc.edu

ABSTRACT

PURPOSE: Although advances have been made in the treatment of AIDS-related Kaposi’s sarcoma (AIDS-KS) with systemic chemotherapy, less toxic therapies are needed. IM862 is a naturally occurring peptide with antiangiogenic properties and was thus studied in patients with AIDS-KS.

PATIENTS AND METHODS: IM862 was given as intranasal drops at a dose of 5 mg. Patients were randomized to two dosing schedules given in repeated cycles until disease progression or unacceptable toxicity: 5 days of therapy followed by 5 days off (n = 18) and every other day dosing (n = 26).

RESULTS: Forty-two male patients and two female patients with a median age of 38 years (range, 22 to 53 years) were accrued. Twenty-one patients (47%) had more than 50 mucocutaneous lesions, 14 (32%) had lymphedema, and none had visceral involvement. Thirty-three patients (75%) had received prior systemic chemotherapy. Twenty-four patients (55%) had CD4⁺ lymphocyte count 200/mm³. All but five patients were being treated with concurrent protease inhibitor(s), for a median of 10 months (range, 0 to 24 months). Major responses were documented in 36%, with five complete and 11 partial remissions, occurring after a median of 6 weeks (range, 3 to 26 weeks) and lasting a median of 33+ weeks (range, 12+ to 95+ weeks). Twenty-one patients had stable disease for periods of 7 to 72+ weeks. Adverse effects to IM862 were limited to mild and transient headache, fatigue, tingling, and nausea. No hematologic adverse effects attributed to treatment were reported.

CONCLUSION: IM862 given as intranasal drops is well tolerated and has antitumor activity in patients with AIDS-KS. A randomized double-blinded study to define the activity of IM862 in patients with AIDS-KS is in progress.

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