© 1997 by Oxford University Press
Journal Of The National Cancer Institute, Vol 89, 1797-1802, Copyright © 1997 by Oxford University Press
PS Gill, T McLaughlin, BM Espina, A Tulpule, S Louie, Y Lunardi-Iskandar and RC Gallo
BACKGROUND: In vitro and in vivo clinical studies have shown that certain
preparations of human chorionic gonadotropin have antitumor activity
against Kaposi's sarcoma, the most common tumor in patients infected with
human immunodeficiency virus type 1 (HIV-1). METHODS: A phase I trial was
conducted in 18 male patients with acquired immunodeficiency
syndrome-related Kaposi's sarcoma. Successive cohorts of six patients each
received human chorionic gonadotropin (A.P.L.; Wyeth-Ayerst, Radnor, PA)
subcutaneously at doses of 5000 IU daily (level I), 10,000 IU three times a
week (level II), or 10,000 IU daily (level III). Toxic effects, changes in
reproductive hormone levels, HIV- 1 RNA plasma levels, and response to
therapy were evaluated. RESULTS: A.P.L. treatment was well tolerated at all
dose levels, and no maximum- tolerated, dose-defined toxic effects were
observed at the highest dose tested. The most common side effects were
weight gain, increased libido, and increased energy. A persistent increase
in testosterone level and a persistent decline in luteinizing hormone and
follicle- stimulating hormone levels were seen over time. Major responses
were observed in six patients. Partial remissions (> or =50% decrease in
lesion numbers, volume, or surface area) were observed at dose level I and
dose level II (two patients each); biopsy-confirmed complete remissions
(resolution of all lesions) were observed at dose level III (two patients).
All but one major response have persisted from 207 to more than 515 days.
Nine patients had stable disease lasting 10 weeks or longer. CONCLUSIONS:
A.P.L. given at daily doses ranging from 5000 to 10,000 IU has antitumor
activity in patients with acquired immunodeficiency syndrome-related
Kaposi's sarcoma. A.P.L. can be given for more than 1 year with minimal
side effects. Larger efficacy studies are warranted.
ARTICLES
Phase I study of human chorionic gonadotropin given subcutaneously to patients with acquired immunodeficiency syndrome-related mucocutaneous Kaposi's sarcoma
Department of Internal Medicine, University of Southern California School of Medicine, Los Angeles, USA.
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