AIDS TREATMENT NEWS Issue #213, December 23, 1994
DOX-SL (TM) (liposomal doxorubicin), an experimental treatment
for Kaposi's sarcoma, will now be available through a new trial
to persons who have failed systemic combination chemotherapy.
DOX-SL is a conventional chemotherapy drug (doxorubicin), but
in a new form which causes it to be targeted better to KS
lesions. DOX-SL is also being tested as a treatment for some
solid-tumor cancers. (For a short background article, see "KS:
DOX-SL Submitted for Approval," AIDS TREATMENT NEWS #208,
October 7, 1994.)
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.)