Study of 124I-NM404 in Advanced Solid Malignancies

Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer Clinical Trial

Official title:

A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01662284
• Other study ID #: CO12901
• Secondary ID: 2012-0230A534260
• Status: Terminated
• Start date: July 2012
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Cellectar Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal Imaging Parameters	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	2 years
Secondary	Adverse events	Number and grade of adverse events attributable to 124I-NM-404	2 years
Secondary	PET comparison	compare 18F-FDG PET to 124I-NM404 PET	2 years

External Links

•   University of Wisconsin Carbone Cancer Center