Clinical trial NCT01662284: Study of 124I-NM404 in Advanced Solid Malignancies
Official title: A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Cellectar Biosciences, Inc.
First posted: 2012-08-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Optimal Imaging Parameters
timeFrame: 2 years
Secondary outcomes:
measure: Adverse events
timeFrame: 2 years
measure: PET comparison
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Glenn Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: