NM404 as an Imaging Agent in Patients With NSCLC

This study is currently recruiting participants.
Verified January 2014 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Novelos Therapeutics
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
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
Novelos Therapeutics
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 April 17, 2014