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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

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