This early phase I trial studies how well positron emission tomography (PET)/computed tomography (CT) imaging with fluorine F 18 clofarabine work in detecting cancer in patients with melanoma that has spread to other places in the body (advanced or metastatic). Diagnostic drugs, such as fluorine F 18 clofarabine, may be absorbed by cancer cells. PET/CT imaging may be used to see where diagnostic drugs go in the body. PET/CT imaging with fluorine F 18 clofarabine may be used for imaging cancer and its response after treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03409419.
PRIMARY OBJECTIVES:
I. How fluorine F 18 clofarabine ([18F] clofarabine [CFA]) is distributed in the body of cancer patients.
II. Whether the [18F] CFA bio-distribution is different before and after immunotherapy treatment.
III. Whether the expression of dCK in immune cells of patients with metastatic or recurrent advanced cancer melanoma is affected by immunotherapy treatment.
SECONDARY OBJECTIVE:
I. Determine whether changes in the [18F] CFA bio-distribution in response to treatment correlates with Response Evaluation Criteria in Solid Tumors (RECIST) after start of immunotherapy.
EXPLORATORY OBJECTIVES:
I. Determine whether 18F-CFA assay of dCK correlates with dCK expression in tumor infiltrating immune cells in resected tumor tissues or biopsy samples.
II. Determine whether 18F-CFA assay of dCK correlates with immune cell activation in resected tumor tissues or biopsy samples.
OUTLINE:
Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo PET/CT scan over approximately 120 minutes minimum of 24 hours before and 2-4 weeks after the first scheduled immunotherapy intervention.
After completion of study, patients are followed up periodically.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorAntoni Ribas
