BB4 antibody-Iodine 131
DrugInjection of an antibody after labelling with Iodine 131
NCT Number: NCT01296204
The first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing doses of iodine 131. At least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side effects, medium and long terms will be analyzed. After determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. These patients will be followed for 1 year after injection therapy.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Centre René Gauducheau, Nantes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with other cancers except uterine carcinoma in situ or basal cell skin carcinoma
Injection of an antibody after labelling with Iodine 131
Centre René Gauducheau
Other
Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131
Acronym: BB4
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