Study of 124I-NM404 in Advanced Solid Malignancies

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be referred to the Phase I oncology research office by their treating oncologist. Outside referrals will be managed by Cancer Connect who will ensure that potential subjects are first evaluated by a UW medical oncologist in the cancer clinic who will then refer them, if appropriate, to the Phase I oncology office.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.
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.
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Cellectar Biosciences, Inc.

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: CO12901; A534260 (Other Identifier: UW Madison); SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison); 2012-0230 (Other Identifier: Institutional Review Board); NCI-2012-01953 (Registry Identifier: NCI Trial ID)