Abstract | PURPOSE: PATIENTS AND METHODS: UICC stage IB-IV NSCLC patients were eligible, if they had at least one prior therapy. Other inclusion criteria were: age 18-75 years, adequate bone marrow function and AST or gamma-GT<or=2.5 ULN. Escalating doses of catumaxomab were administered over 8 h as a continuous intravenous infusion. Dose escalation started at 2 microg and was increased to 7.5 microg. In addition various doses of dexamethasone as premedication were investigated. All patients were pretreated with antihistamines. RESULTS: Dose limiting toxicity (DLT) was a grade 3 and 4 elevation of ALT, AST and gamma-GT, which was observed in dose level IV (10 mg dexamethasone premedication, 5 microg catumaxomab) and V (40 mg dexamethasone followed by 7.5 microg catumaxomab). Elevated liver enzymes decreased to grade 2 within 3-7 days and were at baseline level within 14 days after infusion. The maximum tolerated dose (MTD) was defined in dose level III (40 mg of dexamethasone followed by 5 microg of catumaxomab). CONCLUSIONS:
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Authors | Martin Sebastian, Bernward Passlick, Hilke Friccius-Quecke, Michael Jäger, Horst Lindhofer, Frank Kanniess, Rainer Wiewrodt, Eckhard Thiel, Roland Buhl, Alexander Schmittel |
Journal | Cancer immunology, immunotherapy : CII
(Cancer Immunol Immunother)
Vol. 56
Issue 10
Pg. 1637-44
(Oct 2007)
ISSN: 0340-7004 [Print] Germany |
PMID | 17410361
(Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)
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Chemical References |
- Antibodies, Bispecific
- Antibodies, Monoclonal
- Antigens, Neoplasm
- Antineoplastic Agents
- CD3 Complex
- Cell Adhesion Molecules
- EPCAM protein, human
- Epithelial Cell Adhesion Molecule
- catumaxomab
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Topics |
- Adolescent
- Adult
- Aged
- Animals
- Antibodies, Bispecific
(adverse effects, therapeutic use)
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antigens, Neoplasm
(immunology)
- Antineoplastic Agents
(adverse effects, therapeutic use)
- CD3 Complex
(immunology)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Cell Adhesion Molecules
(immunology)
- Disease Progression
- Epithelial Cell Adhesion Molecule
- Female
- Humans
- Lung Neoplasms
(drug therapy, pathology)
- Male
- Mice
- Middle Aged
- Rats
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