NCT00364364

Safety Study to Determine the Appropriate Dose of Antibody Against Tumor Cells to Best Target Patients With Pancreatic Cancer.

Pharmacokinetics, Biodistribution and Targeting of 111 In- Labeled Humanized PAM4IgG in Pre-Surgical Pancreatic Cancer Patients.An Examination of Protein Dose

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This no treatment research study is being done to find a safe and an appropriate dose of antibody (protein) against tumor cells to best target the cancer in people with pancreatic cancer. To do this, this no-treatment research study will compare two doses of an antibody called hPAM4 IgG when combined with a radioactive element, Indium-111.

Detailed description

This is an open-label, single-center, non-randomized, single-arm, pilot imaging study to determine the pharmacokinetics, biodistribution, and tumor targeting of an indium-111 (111In)-labeled, humanized anti-MUC1 antibody, designated hPAM4 IgG1 in patients with known pancreatic cancer. The primary objective of this trial is to examine how changing the protein dose will affect these parameters with the intent to determine if a single protein dose can be selected to optimize tumor targeting. It is expected that these data will aid in the selection of an appropriate protein dose to be used in a Phase I therapy trial with yttrium-90 (90Y)-labeled hPAM4 IgG. The secondary objective is to monitor safety. Pharmacokinetics, biodistribution, tumor targeting, and dosimetry (modeling for 90Y) will be assessed against clinical parameters, such as pre-study PAM4-reactive MUC-1 antigen in the serum, tumor size, location, histopathology, immunohistology, and if possible, antigen content by extraction of tumor sample.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Radiolabeled humanized PAM4 IgG

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-08-15
• Last updated: 2019-01-18

Locations

1 site across 1 country: United States