Phase I study of human chorionic gonadotropin given subcutaneously to patients with acquired immunodeficiency syndrome-related mucocutaneous Kaposi's sarcoma
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). A phase I trial was conducted in 18 male pati...
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Published in | JNCI : Journal of the National Cancer Institute Vol. 89; no. 23; pp. 1797 - 1802 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
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Cary, NC
Oxford University Press
03.12.1997
Oxford Publishing Limited (England) |
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Abstract | 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).
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.
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.
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. |
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AbstractList | 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).
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.
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.
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. 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. |
Author | ESPINA, B. M MCLAUGHLIN, T GILL, P. S LOUIE, S TULPULE, A LUNARDI-ISKANDAR, Y GALLO, R. C |
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Keywords | Antineoplastic agent Human Immunopathology Skin disease AIDS Gonadotropin Malignant tumor Glycoprotein hormone Immune deficiency HCG Placental hormone Infection Kaposi sarcoma Chemotherapy Treatment Viral disease Phase I trial Complication Subcutaneous administration |
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References | (4_37666383) 1991; 10 Gill (9_15801711) 1994; 8 Bourinbaiar (18_9947165) 1992; 309 Saal (20_9512046) 1991; 56 (14_23932307) 1983; 78 Chak (3_4908046) 1988; 6 Jones (19_15594709) 1994; 131 Gelmann (6_14082976) 1987; 82 Gill (8_9124431) 1990; 13 Green (13_10112696) 1992; 10 (16_37666385) 1996; 10 Gill (7_9426774) 1991; 90 Lunardi-Iskandar (11_15847146) 1995; 375 Glass (17_15827004) 1994; 23 (10_37666384) 1994; 7 Hoover (2_14424811) 1993; 138 Kovacs (5_34412611) 1989; 111 Gill (12_16421837) 1996; 335 |
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Snippet | In vitro and in vivo clinical studies have shown that certain preparations of human chorionic gonadotropin have antitumor activity against Kaposi's sarcoma,... BACKGROUND: In vitro and in vivo clinical studies have shown that certain preparations of human chorionic gonadotropin have antitumor activity against Kaposi's... |
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SubjectTerms | Acquired immune deficiency syndrome Acquired Immunodeficiency Syndrome - complications Adult AIDS Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - therapeutic use Biological and medical sciences Chemotherapy Chorionic Gonadotropin - administration & dosage Chorionic Gonadotropin - therapeutic use Dose-Response Relationship, Drug Drug Administration Schedule Drug therapy Humans Injections, Subcutaneous Kaposis sarcoma Male Medical research Medical sciences Middle Aged Pharmacology. Drug treatments Sarcoma, Kaposi - drug therapy Sarcoma, Kaposi - virology Skin Neoplasms - drug therapy Skin Neoplasms - virology Treatment Outcome |
Title | Phase I study of human chorionic gonadotropin given subcutaneously to patients with acquired immunodeficiency syndrome-related mucocutaneous Kaposi's sarcoma |
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