AIDS TREATMENT NEWS Issue #213, December 23, 1994
John S. James
This trial is for patients with AIDS-related Kaposi's sarcoma, who have received systemic combination chemotherapy (with two drugs, not including interferon, given together), and either are intolerant to the combination chemotherapy, or have had disease progression after receiving at least two cycles of it. "Intolerance" is defined as grade IV toxicity, or more than one episode of grade III toxicity on the same regimen; "disease progression" is defined as new visceral sites, or progression of visceral disease, or development of new or increasing KS-associated edema lasting at least one week and interfering with normal activities, or a 25 percent increase in the number of lesions, or a change of 25 percent or more of all previously "flat" lesions to "raised." There are also other entry requirements, including cardiac ejection fraction >50 percent, hemoglobin >9, neutrophil count >1,200, platelet count >75,000, and bilirubin and creatinine both less than twice the upper limit of normal.
The new study protocol will also be available to patients who have been participating in DOX-SL protocols 30-10, 30-11, or 30-12, and for whom continuation of DOX-SL is medically indicated.
This protocol will be available at sites in the following cities:
Atlanta (2 sites), Austin, Berkeley (CA), Boston (2 sites), Chicago (2 sites), Dallas, Detroit, Encino (CA), Houston (3 sites), Los Angeles (3 sites), Miami, New Orleans, New York (5 sites), Philadelphia, Phoenix, Roswell Park (NY), San Diego, San Francisco (4 sites), Seattle, St. Louis, Tampa, and Washington, DC. Also, in a limited number of cases, the drug will be available to patients elsewhere, through their physicians.
Liposome Technology, Inc., which is developing DOX-SL, will make the drug available without charge. However, it will not pay for infusion costs or other expenses.
For more information about this study, which is called protocol 30-25, physicians will be able to call 800/KAPOSIS. (Note: On December 16, as we go to press, this number has not yet been connected. Also, some of the above sites will start the new protocol in January -- or in a few cases, in February -- because they are waiting for approval from their Institutional Review Board.)
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