A Safety Study of 212Pb-Pentixather Radioligand Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 212-Lead Pentixather, 203-Lead Pentixather SPECT/CT.
- Who it may be relevant to
- Registry conditions: Carcinoid Tumor Lung, Neuroendocrine Tumor of the Lung, Carcinoma, Small-Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
Overview
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
Interventions
- Drug 212-Lead Pentixather
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand. - Diagnostic test 203-Lead Pentixather SPECT/CT
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
Primary outcome measures
- Determine the recommended phase 2 dose of 212-Lead Pentixather [Time frame: 3 months]
Secondary outcome measures (2)
- Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT [Time frame: baseline]
- Determine tumor response [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Iowa Health Care — Iowa City
Publications
- Schottelius M, Osl T, Poschenrieder A, Hoffmann F, Beykan S, Hanscheid H, Schirbel A, Buck AK, Kropf S, Schwaiger M, Keller U, Lassmann M, Wester HJ. [177Lu]pentixather: Comprehensive Preclinical Characterization of a First CXCR4-directed Endoradiotherapeutic Agent. Theranostics. 2017 Jun 11;7(9):2350-2362. doi: 10.7150/thno.19119. eCollection 2017. PMID 28744319
- Buck AK, Serfling SE, Lindner T, Hanscheid H, Schirbel A, Hahner S, Fassnacht M, Einsele H, Werner RA. CXCR4-targeted theranostics in oncology. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4133-4144. doi: 10.1007/s00259-022-05849-y. Epub 2022 Jun 8. PMID 35674738
- Serfling SE, Lapa C, Dreher N, Hartrampf PE, Rowe SP, Higuchi T, Schirbel A, Weich A, Hahner S, Fassnacht M, Buck AK, Werner RA. Impact of Tumor Burden on Normal Organ Distribution in Patients Imaged with CXCR4-Targeted [68Ga]Ga-PentixaFor PET/CT. Mol Imaging Biol. 2022 Aug;24(4):659-665. doi: 10.1007/s11307-022-01717-1. Epub 2022 Mar 21. PMID 35312939
Identifiers
NCT: NCT05557708 · SPORE Project 2 · 1P50CA302572-01