NCT01384253

Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy

Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Orano Med LLC · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-10-01
• Completion: 2016-07-01
• First posted: 2011-06-29
• Last updated: 2016-09-30

Locations

2 sites across 1 country: United States