An Early Phase 1 interventional study of Copper Cu 64-DOTA-pembrolizumab and Positron Emission Tomography in Metastatic Malignant Solid Neoplasm, sponsored by City of Hope Medical Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by City of Hope Medical Center · Early Phase 1, Interventional, and Treatment
This clinical trial tests how well using 64Cu-DOTA pembrolizumab (64CDP) with positron emission tomography (PET) scans works to find tumor cells in patients with cancers that have spread from where it first started to other places in the body (metastatic). 64CDP is a compound with pembrolizumab that is joined with a radioactive substance used for diagnostic purpose. Pembrolizumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Targeted drugs such as pembrolizumab may the improve uptake of the radioactive substance in tumor cells. 64CDP may improve ability to evaluate response to treatment in patients with solid tumors.
PRIMARY OBJECTIVES:
I. To describe toxicities of 64Cu-DOTA-pembrolizumab (64CDP) positron emission tomography, by evaluation of toxicities including: type, frequency, severity, attribution, time course, and duration.
II. To identify changes in 64Cu-DOTA-pembrolizumab (64CDP) uptake in radiated metastatic lesions pre- and post-SBRT.
OUTLINE:
Patients receive standard of care pembrolizumab intravenously (IV) at baseline. Patients then receive 64CDP IV days 1 and 29 on study. Patients undergo PET scan on days 2 and 30 on study. Patients also undergo standard of care SBRT days 8-18.
City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Documented informed consent of the participant and/or legally authorized representative.
Contraception:
Exclusion Criteria:
Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:
Patients receive standard of care pembrolizumab IV at baseline. Patients then receive 64CDP IV days 1 and 29 on study. Patients undergo PET scan on days 2 and 30 on study. Patients also undergo standard of care SBRT days 8-18.
Drug: Copper Cu 64-DOTA-pembrolizumab · Procedure: Positron Emission Tomography · Radiation: Stereotactic Body Radiation Therapy
Given IV
Also known as: 64Cu-DOTA-pembrolizumab, 64Cu-labeled Pembrolizumab, 64Cu-pembrolizumab, Copper Cu 64 Pembrolizumab
Undergo PET scan
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Dose Limiting Toxicities (DLT)
Defined as any infusion-related reactions, hematologic or non-hematologic toxicities that occur during the first 3 days post administration of study drug that are possibly related to protocol therapy. DLT adverse events will be monitored continuously. Toxicities will be summarized in terms of type, severity, time of onset, duration, and association with study treatment.
Time frame: After administration of study treatment up to 1 month
Changes in 64CDP uptake
T-test to determine significance. T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT.
Time frame: From baseline through study completion, an average of 6 weeks
Change in standard-uptake-value (SUV-max)
T-test to determine significance.
Time frame: From baseline through study completion, an average of 6 weeks
Incidence of adverse events
Defined as any infusion-related reactions, hematologic or non-hematologic toxicities that occur during the first 3 days post administration of study drug that are possibly related to protocol therapy. Dose limiting toxicity (DLT) adverse events will be monitored continuously. Toxicities will be summarized in terms of type, severity, time of onset, duration, and association with study treatment.
Time frame: After administration of study treatment up to 1 month
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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