NM404 as an Imaging Agent in Patients With NSCLC

University of Wisconsin (UW)

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: I124-NM404

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00582283

CO02505

124I-CLR1404 (Other Grant/Funding Number)

R21CA092412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Diagnostic: iodine I-124 NM404 CT/PET scan

Other group

Description:

Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.

Treatment:

Drug: I124-NM404