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Radioimmunotherapy With 131I-L19SIP in Patients With Cancer

NCT01242943 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-11-22

No results posted yet for this study

Summary

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I study.

Conditions

  • Patients With Cancer

Interventions

DRUG

131I-L19SIP Radioimmunotherapy (RIT)

Dosimetric evaluation with 131I-L19SIP will be performed to assess eligibility for Radioimmunotherapy. Phase I: Patients eligible for Radioimmunotherapy will receive escalating doses of therapeutic 131I-L19SIP administration (intravenously) at the following dosages (expressed in mCi/m2): 111, 139 and 167.

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giuliano Mariani, Prof · University Hospital Pisa, Italy

  • Tim Meyer, Dr · University College London (UCL) Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-02-28
Completion
2011-05-31

Countries

  • Italy
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242943 on ClinicalTrials.gov