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Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy

NCT01384253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-09-30

No results posted yet for this study

Summary

Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases.

This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.

Conditions

  • Breast Neoplasms
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Stomach Neoplasms

Interventions

OTHER

²¹²Pb-TCMC-Trastuzumab

The starting dose level will be 200 μCi/m² of ²¹²Pb-TCMC-Trastuzumab. Three to six patients will be treated at each dose level, and dose escalation will proceed if no more than 1 out of 6 patients in a cohort experiences dose limiting toxicity. Six patients will be treated at the maximum tolerated dose.

BIOLOGICAL

trastuzumab

4 mg/kg.

Sponsors & Collaborators

  • Orano Med LLC

    lead INDUSTRY

Principal Investigators

  • Ruby F Meredith, M.D., Ph.D. · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-10-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01384253 on ClinicalTrials.gov