Study of 124I-NM404 in Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Cellectar Biosciences, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01662284
First received: August 3, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.


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:


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: 108
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Prostate
124I-NM404 in prostate cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Colorectal
124I-NM404 in colorectal cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Gastric
124I-NM404 in gastric cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Ovarian
124I-NM404 in ovarian cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Pancreatic
124I-NM404 in pancreatic cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Esophageal
124I-NM404 in esophageal cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Sarcoma
124I-NM404 in soft tissue sarcoma
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
Experimental: Head & Neck
124I-NM404 in head and neck cancer
Drug: 124I-NM404
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.

Detailed Description:

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.

  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
  • Anticipated survival less than 5 years, as per the treating physician

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 75,000/uL
  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: 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
Cellectar Biosciences, Inc.
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: July 17, 2014
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:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014