NM404 as an Imaging Agent in Patients With NSCLC

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete).

In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3

• ongoing).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: Cellectar Biosciences, Inc.; National Cancer Institute (NCI)

Criteria

Inclusion Criteria: Part 3

• Histologically or cytologically documented NSCLC with measurable of disease

• Disease is evaluable by CT scan

• At least 18 years old. Women cannot be pregnant or breastfeeding

• Karnofsky score >/= to 60

• Adequate renal/hepatic function

• Adequate blood cell count levels

Exclusion Criteria:

• Concomitant infection

• Other active cancers