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Clinical Cancer Research Vol. 9, 3578-3588, September 1, 2003
© 2003 American Association for Cancer Research

Clinical Trials

Phase I Clinical Trial of Histone Deacetylase Inhibitor

Suberoylanilide Hydroxamic Acid Administered Intravenously1

Wm. Kevin Kelly2, Victoria M. Richon, Owen O’Connor, Tracy Curley, Barbara MacGregor-Curtelli, William Tong, Mark Klang, Lawrence Schwartz, Stacie Richardson, Eddie Rosa, Marija Drobnjak, Carlos Cordon-Cordo, Judy H. Chiao, Richard Rifkind, Paul A. Marks and Howard Scher

Genitourinary Oncology Service [W. K. K., H. S.], Lymphoma Service [O. O.], Departments of Medicine [W. K. K., O. O., H. S.], Nursing [T. C., B. M-C.], Pharmacy [M. K.], Radiology [L. S.], Epidemiology and Biostatistics [S. R.], and Pathology [M. D., C. C-C.], Laboratory of Analytical Pharmacology [W. T.], and Cell Biology Program of Sloan-Kettering Institute [R. R., P. A. M.], Memorial Sloan-Kettering Cancer Center and Joan and Sanford Weill Medical College of Cornell University, New York, New York 10021, and Aton Pharma, Inc., Tarrytown, New York [V. M. R., E. R., J. H. C.]

Purpose: To evaluate the safety, pharmacokinetics, and biological activity of suberoylanilide hydroxamic acid (SAHA) administered by 2-h i.v. infusion in patients with advanced cancer.

Experimental Design: SAHA was administered for 3 days every 21 days in part A and 5 days for 1–3 weeks in part B. Dose escalation proceeded independently in patients with solid tumor and hematological malignancies (part B only). Pharmacokinetic studies were performed along with assessment of acetylated histones in peripheral blood mononuclear cells and tumor tissues.

Results: No dose-limiting toxicities were observed in 8 patients enrolled in part A (75, 150, 300, 600, and 900 mg/m2/day). Among 12 hematological and 17 solid tumor patients enrolled in part B (300, 600, and 900 mg/m2/day), therapy was delayed >=1 week for grade 3/4 leukopenia and/or thrombocytopenia in 2 of 5 hematological patients at 600 mg/m2/day x 5 days for 3 weeks. The maximal-tolerated dose was 300 mg/m2/day x 5 days for 3 weeks for hematological patients. One solid patient on 900 mg/m2/day x 5 days for 3 weeks developed acute respiratory distress and grade 3 hypotension. The cohort was expanded to 6 patients, and no additional dose-limiting toxicities were observed. Mean terminal half-life ranged from 21 to 58 min, and there was dose-proportional increase in area under the curve. An accumulation of acetylated histones in peripheral blood mononuclear cells up to 4 h postinfusion was observed at higher dose levels. Posttherapy tumor biopsies showed an accumulation of acetylated histones by immunohistochemistry. Four (2 lymphoma and 2 bladder) patients had objective tumor regression with clinical improvement in tumor related symptoms.

Conclusions: Daily i.v. SAHA is well tolerated, inhibits the biological target in vivo, and has antitumor activity in solid and hematological tumors.




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