[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative]

[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative] Research Abstract Details 

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[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative] Abstract Text:

Feng-Hua Wang,Yu-Hong Li,Su Li,Wen-Qi Jiang,Zhong-Zhen Guan,

BACKGROUND & OBJECTIVE: Intravenous recombinant human lymphotoxin-alpha derivative (rhLTalpha-Da) is a novel biological antitumor reagent developed in China. This study was to evaluate the tolerance of tumor patients to rhLTalpha-Da, confirm its maximum tolerable dose (MTD) in vivo, and to provide recommending dose for phase II trial. METHODS: The dose escalation of rhLTalpha-Da was as follows: 10 microg.(m2.day)-1, 20 microg.(m2.day)-1, and 33 microg.(m2.day)-. Each group contained at least 3 patients. rhLTalpha-Da was solved in 5% GS (100 ml), and intravenously infused over 30 minutes daily for 5 consecutive days. RESULTS: A total of 24 patients were enrolled. Grade I-III chill and fever were the most common adverse events, with the occurrence rate of 79.2% (19/24). Other adverse events observed were dyspnea (3/24), nausea/vomiting (3/24), headache (4/24), fatigue (2/24), hypotension (2/24), and skin discomfort at irradiation region (2/24). No obvious abnormity of liver and renal functions was observed. The dose-limiting toxicities (DLT), which occurred at dose level of 33 microg.(m2.day)-1, were grade III chill, grade III fever, and grade III dyspnea. Although there was no definite efficacy showed in this primary study, initial response to rhLTalpha-Da was seen on a minority of patients with cancers, including malignant melanoma, mycosis fungoides, and renal carcinoma. CONCLUSIONS: The MTD of rhLTalpha-Da is 33 microg.(m2.day)-1. The recommended dose for phase II clinical trial is 20 microg.(m2.day)-1.

[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative] Publishing Authors By Initials

FH Wang,YH Li,S Li,WQ Jiang,ZZ Guan,

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[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative] Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Ai zheng = Aizheng = Chinese journal of cancer

VOLUME: 25

Page Numbers: 501-4

Journal Abbreviation: Ai Zheng

ISSN: 1000-467X

DAY: 14

MONTH: Apr

YEAR: 2006

[Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative] Information

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LANGUAGE: chi

NlmUniqueID: 9424852

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Grant and Affiliation Information for [Phase I clinical trial of intravenous recombinant human lymphotoxin-alpha derivative]

AFFILIATION: State Key Laboratory of Oncology in South China, Guangzhou, Guangdong 510060, P. R. China.

Country: China

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MEDLINETA: Ai Zheng

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