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Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: Clinical Phase I/II trials
- Source :
- International Journal of Radiation Oncology*Biology*Physics. 65:435-444
- Publication Year :
- 2006
- Publisher :
- Elsevier BV, 2006.
-
Abstract
- Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ( 131 I) metuximab injection (Licartin), a novel 131 I-labeled HAb18G/CD147-specific monoclonal antibody F(ab') 2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. Methods and Materials: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. Results: No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56–63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles ( p p = 0.0019). Conclusion: Iodine ( 131 I) metuximab injection is safe and active for HCC patients.
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
Carcinoma, Hepatocellular
Adolescent
Maximum Tolerated Dose
medicine.medical_treatment
Antineoplastic Agents
Gastroenterology
law.invention
Iodine Radioisotopes
Pharmacokinetics
Randomized controlled trial
law
Internal medicine
Carcinoma
Humans
Medicine
Radiology, Nuclear Medicine and imaging
Survival rate
Aged
Radiation
business.industry
Liver Neoplasms
Antibodies, Monoclonal
Middle Aged
Radioimmunotherapy
medicine.disease
Surgery
Clinical trial
Drug Combinations
Oncology
Hepatocellular carcinoma
Basigin
Female
business
Progressive disease
Subjects
Details
- ISSN :
- 03603016
- Volume :
- 65
- Database :
- OpenAIRE
- Journal :
- International Journal of Radiation Oncology*Biology*Physics
- Accession number :
- edsair.doi.dedup.....7d1cdd5659dec62ccc6e436d745e1909