NM404 as an Imaging Agent in Patients With NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Cellectar Biosciences, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582283
First received: December 19, 2007
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Non Small Cell Lung Cancer
Other: I-131-NM404
Drug: I124-NM404

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Imaging characteristics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor accumulation and metabolic fate of NM404 in tissue [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Imaging Data [ Time Frame: 1, 2, 3 and 5-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: January 2004
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part 1 and 2
I-131-NM404
Other: I-131-NM404
I-131-NM404
Part 3
I-124-NM404
Drug: I124-NM404
I-124-NM404

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582283

Contacts
Contact: Cancer Connect 800-622-8922 uwccc@uwccc.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Anne Traynor, MD    608-262-5092      
Principal Investigator: Anne Traynor, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Cellectar Biosciences, Inc.
Investigators
Principal Investigator: Anne M Traynor, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582283     History of Changes
Other Study ID Numbers: H-2002-582, R21CA092412, CO02505, 124I-CLR1404
Study First Received: December 19, 2007
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014