Study of 124I-NM404 in Advanced Solid Malignancies

Terminated

• Conditions: Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
• Interventions: Drug: 124I-NM404

• Registration Number: NCT01662284
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-01
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sarcoma	124I-NM404	124I-NM404 in soft tissue sarcoma
Colorectal	124I-NM404	124I-NM404 in colorectal cancer
Gastric	124I-NM404	124I-NM404 in gastric cancer
Esophageal	124I-NM404	124I-NM404 in esophageal cancer
Triple Negative Breast	124I-NM404	124I-NM404 in triple negative breast cancer
Head & Neck	124I-NM404	124I-NM404 in head and neck cancer
Prostate	124I-NM404	124I-NM404 in prostate cancer
Ovarian	124I-NM404	124I-NM404 in ovarian cancer
Pancreatic	124I-NM404	124I-NM404 in pancreatic cancer

Primary Outcome Measures

Name	Time	Method
Optimal Imaging Parameters	2 years	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

Name	Time	Method
PET comparison	2 years	compare 18F-FDG PET to 124I-NM404 PET
Adverse events	2 years	Number and grade of adverse events attributable to 124I-NM-404

Trial Locations

Locations (1)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States