Study of 124I-NM404 in Advanced Solid Malignancies
Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
Conditions: official terms
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: 124I-NM404
Type: Drug
Overall Status
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Status: Recruiting
Start Date
July 2012
Completion Date
July 2016
University of Wisconsin, Madison
University of Wisconsin, Madison
Record processing date processed this data on July 28, 2015 page