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Trial Title:
A Safety Study of 212Pb-Pentixather Radioligand Therapy
NCT ID:
NCT05557708
Condition:
Carcinoid Tumor Lung
Neuroendocrine Tumor of the Lung
Carcinoma, Small-Cell Lung
Conditions: Official terms:
Carcinoma
Neuroendocrine Tumors
Carcinoid Tumor
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Lung Neoplasms
Conditions: Keywords:
radioligand therapy
pentixather
Lead 203
Lead 212
alpha therapy
dosimetry
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
212-Lead Pentixather
Description:
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
Arm group label:
212-Lead Pentixather
Intervention type:
Diagnostic Test
Intervention name:
203-Lead Pentixather SPECT/CT
Description:
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant
lesions for dosimetric analysis and treatment planning.
Arm group label:
212-Lead Pentixather
Summary:
This is a first-in-human clinical trial evaluating the safety of an alpha-radiation
treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and
previously treated, for atypical carcinoid lesions of the lung.
Detailed description:
This is a study to determine what dose is acceptably safe for further testing.
In this study, participants are asked to:
- undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the
tumor lesions have the needed receptors
- undergo serial blood sampling for during and after the SPECT/CT scan for radiation
and dosimetry calculations (to determine how much of the Lead-212 Pentixather to
administer)
- receive up to 2 infusions of arginine & lysine as a kidney protectant
- receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion
- undergo imaging at 3 months post treatment to determine disease response
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ability to provide independent consent
- adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL;
neutrophil count ≥ 1,500 cells/mm3)
- adequate kidney function (creatinine clearance of ≥ 50 mL/min using the
Cockcroft-Gault equation
- adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x
the upper limit of normal, and ALT ≤ 5x the upper limit of normal)
- failed initial therapy or declined further therapy known to confer benefit
- have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by
Lead-203 Pentixather SPECT/CT
Exclusion Criteria:
- major surgery within 4 weeks of consent
- antoher investigational agent within 4 weeks of consent
- uncontrolled illness including, but not limited to, ongoing or active infection that
would necessitate a delay in therapy or cause a hospital admission, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic
cirrhosis or severe impairment, or psychiatric illness/social situations that would
limit compliance with study requirements.
- prior solid organ transplant
- cytotoxic or antineoplastic therapy within 21 days of consent (42 days for
nitrosoureas)
- antibody therapy within the 21 days of consent
- allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84
days of consent
- pregnancy
- breastfeeding
- refusal to comply with birth control requirements during study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Iowa Theranostics Center
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Contact:
Last name:
Yusuf Menda, MD
Phone:
319-356-3214
Email:
yusuf-menda@uiowa.edu
Contact backup:
Last name:
Kristin Gaimari-Varner, RN
Email:
kristin-gaimari-varner@uiowa.edu
Investigator:
Last name:
Yusuf Menda, MD
Email:
Principal Investigator
Investigator:
Last name:
Stephen Graves, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Chandrikha Chandrasekharan, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Joseph Dillon, MD
Email:
Sub-Investigator
Investigator:
Last name:
David Bushnell, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Graham, MD, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Janet Pollard, MD
Email:
Sub-Investigator
Start date:
July 1, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Yusuf Menda
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Holden Comprehensive Cancer Center
Agency class:
Other
Source:
University of Iowa
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557708