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Study of 124I-NM404 in Advanced Solid Malignancies

This study is currently recruiting participants.
Verified August 2012 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Novelos Therapeutics
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01662284
First received: August 3, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.


Condition Intervention Phase
Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
 Drug: 124I-NM404
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Optimal Imaging Parameters [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Number and grade of adverse events attributable to 124I-NM-404

  • PET comparison [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    compare 18F-FDG PET to 124I-NM404 PET


Estimated Enrollment: 81
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple Negative Breast
124I-NM404 in triple negative breast cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Prostate
124I-NM404 in prostate cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Colorectal
124I-NM404 in colorectal cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Gastric
124I-NM404 in gastric cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Ovarian
124I-NM404 in ovarian cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Pancreatic
124I-NM404 in pancreatic cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Esophageal
124I-NM404 in esophageal cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Sarcoma
124I-NM404 in soft tissue sarcoma
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.
Experimental: Head & Neck
124I-NM404 in head and neck cancer
 Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of advanced solid malignancy.
  • Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer
  • Disease must be at least 1cm in diameter
  • Brain metastasis must be stable for at least one month.
  • ECOG performance status 0-2

Exclusion Criteria:

  • Skin lesions only
  • Chemotherapy or radiotherapy within 1 week
  • Residual toxicities of grade 2 or greater from prior therapy
  • Adequate organ function as per specified laboratory parameter
  • Platelet count > or = to 160,000/uL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662284

Contacts
Contact: Cancer Connect 1-800-622-8922 cancerconnect@uwcarbone.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Glenn Liu, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Novelos Therapeutics
Investigators
Principal Investigator: Glenn Liu, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01662284     History of Changes
Other Study ID Numbers: CO12901
Study First Received: August 3, 2012
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration
United States: University of Wisconsin Carbone Cancer Center Data Safety and Monitoring Committee

Additional relevant MeSH terms:
Esophageal Diseases
Head and Neck Neoplasms
Sarcoma
Gastrointestinal Diseases
Digestive System Diseases
 Neoplasms by Site
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 19, 2013