Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
Conditions
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.
Interventions
DRUG124I-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.
Sponsors
Cellectar Biosciences, Inc.
University of Wisconsin, Madison
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 years | Number and grade of adverse events attributable to 124I-NM-404 |
| PET comparison | 2 years | compare 18F-FDG PET to 124I-NM404 PET |
Countries
United States
Outcome results
None listed