Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Determine the recommended phase 2 dose of 212-Lead Pentixather
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
212-Lead Pentixather
Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints.
Treatment is administered in 2 cycles with 6 weeks between the cycles.
Intervention: 212-Lead Pentixather (Drug)
212-Lead Pentixather
Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints.
Treatment is administered in 2 cycles with 6 weeks between the cycles.
Intervention: 203-Lead Pentixather SPECT/CT (Diagnostic Test)
Outcomes
Primary Outcomes
Determine the recommended phase 2 dose of 212-Lead Pentixather
Time Frame: 3 months
The recommended phase 2 dose is based on the number of dose limiting toxicities observed post-treatment.
Secondary Outcomes
- Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT(baseline)
- Determine tumor response(3 months)
Investigators
Yusuf Menda
Professor and Director, Nuclear Medicine
University of Iowa