Study of 124I-NM404 in Advanced Solid Malignancies

University of Wisconsin (UW)

Status: Terminated

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

Treatments: Drug: 124I-NM404

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01662284

NCI-2012-01953 (Registry Identifier)

2012-0230 (Other Identifier)

CO12901

A534260 (Other Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 9 patient groups

Triple Negative Breast

Description:

124I-NM404 in triple negative breast cancer

Treatment:

Drug: 124I-NM404

Prostate

Description:

124I-NM404 in prostate cancer

Treatment:

Drug: 124I-NM404

Colorectal

Description:

124I-NM404 in colorectal cancer

Treatment:

Drug: 124I-NM404

Gastric

Description:

124I-NM404 in gastric cancer

Treatment:

Drug: 124I-NM404

Ovarian

Description:

124I-NM404 in ovarian cancer

Treatment:

Drug: 124I-NM404

Pancreatic

Description:

124I-NM404 in pancreatic cancer

Treatment:

Drug: 124I-NM404

Esophageal

Description:

124I-NM404 in esophageal cancer

Treatment:

Drug: 124I-NM404

Sarcoma

Description:

124I-NM404 in soft tissue sarcoma

Treatment:

Drug: 124I-NM404

Head & Neck

Description:

124I-NM404 in head and neck cancer

Treatment:

Drug: 124I-NM404