Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

Metastatic Cancer Clinical Trial

Official title:

18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05065736
• Other study ID #: CASE4Y21
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 6, 2023
• Est. completion date: December 5, 2024

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Omar Mian, MD
• Phone: 866-223 8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET/CT, can be used to image cancer pyrimidine metabolism in participants.

PET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.

Description:

The participants will receive a CFA injection into a vein in their arm. The imaging drug is attracted to and taken into certain cells in the body, including cancer cells. 18F-Clofarabine (CFA) is experimental because it is not approved by the Food and Drug Administration (FDA).

The participants will be observed for side effects, and about 1 hour later, they will receive a PET/CT scan. Additionally, they will be contacted the next day to inquire again about any side effects. If the participant's routine care involves repeat imaging of cancer, then the CFA PET/CT scan will be repeated at that time, which could be up to 365 days after the first CFA PET/CT scan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: December 5, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven metastatic cancer (including carcinoma, adenocarcinoma, sarcoma, or neuroendocrine cancer).

• Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest/abdomen/pelvis.

• Subjects must have measurable disease per RECIST 1.1

• Over 18 years of age

• ECOG performance status 0-1

• Adequate organ function as defined by the following criteria (labs may be no more than 4 weeks prior to the screening date):

• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <= 2.5 x laboratory upper limit of normal (ULN)

• Total serum bilirubin <= 2.0 x ULN

• Absolute neutrophil count (ANC) >= 1500/uL

• Platelets >= 75,000/uL

• Hemoglobin >= 8.0 g/dL

• Serum calcium <= 12.0 mg/dL

• Serum creatinine <= 2.9 mg/dL

• Subjects must have the ability to understand and the willingness to sign a written informed consent document

• Patient is able to remain still for the duration of the imaging procedure (up to one hour).

Exclusion Criteria:

• Within 6 months prior to enrollment on this study: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.

• Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.

• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Drug:
• 18F-Clofarabine
The participants enrolled will receive a baseline CFA PET/CT evaluation. Then, the participants will undergo the routine follow up would normally occur for their cancer and its treatment. If this routine follow up and care involves repeat imaging of the cancer, then the CFA PET/CT scan will be repeated at that time (timed according to standard-of-care follow-up imaging), which is expected between a month to about 4 months after the first CFA PET/CT scan. The study period will end 24 hours after this repeat PET/CT scan.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Omar Mian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate CFA as a PET imaging agent	Establish the image-based biodistribution of CFA, a new tracer for imaging DCK enzyme activity. DCK converts the inactive prodrug clofarabine into its active form. Thus, the degree of DCK expression in normal and abnormal tissues may predict drug effects and effectiveness.; The uptake of the radiotracer (SUVs) will be measured quantitatively from PET images taken at 60 min post-injection of [18F]CFA.	up to 60 minutes after CFA PET
Secondary	Correlate CFA uptake with conventional imaging	Correlate CFA uptake with conventional anatomic imaging using RECIST criteria to establish change over time and differences from participants' baseline scans.	up to 3 months after CFA PET
Secondary	Correlate CFA uptake with PFS	Correlate changes in CFA uptake (SUV) with disease progression as determined by standard of care surveillance imaging.	up to 12 months after CFA PET
Secondary	Correlate CFA uptake with OS	Correlate changes in CFA uptake with participant outcomes as measured by all cause mortality/overall survival (OS).	up to 12 months after CFA PET
Secondary	Adverse Events	Proportion of participants who develop any side effects/adverse events associated with radiotracer infusions.	within 48 hrs of radiotracer administration