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NCT06148636
NCT06148636
Who may be able to join
Who might be able to join this trial:
- You are between 18 and 80 years old
- You have been diagnosed with a slow-growing (grade 1 or grade 2) neuroendocrine tumor, confirmed by a tissue or cell sample
- Your cancer cannot be cured by surgery or other treatments, and it has continued to grow or worsen despite all standard treatments available to you
- You have previously received a type of radiation treatment called peptide receptor radionuclide therapy (PRRT)
- You have had a specific type of scan (called a somatostatin receptor PET/CT scan, using an FDA-approved agent) within the past 12 months that showed your tumor has certain receptors on it
- You have at least one tumor that can be measured and is at least 1 cm in size on a CT or MRI scan
- You are in good enough general health to take part (confirm with trial site)
- You do not have another active cancer that needs urgent treatment right now (some slow-growing cancers may still be acceptable with documentation from your cancer doctor)
- You do not have any serious uncontrolled illnesses, such as a major infection, serious heart problems, or conditions that would make it hard to follow the study plan
- You are able to understand the study and are willing to give your consent to take part
- You are willing and able to follow all study requirements for the full length of the study
- You agree to follow certain lifestyle guidelines during the study, including:
- Avoiding red wine, grapefruit, Seville oranges, pomelos, and related fruit juices from the day before treatment through 5 days after each treatment
- Taking your blood pressure medications as prescribed, if you have any
- Avoiding excessive alcohol
- Not taking herbal or natural supplements unless approved by your study doctor
- Using contraception for at least 6 months if you have a uterus, or at least 3 months if you have testes
Who may not be able to join:
- Your platelet count (cells that help blood clot) is too low
- Your white blood cell count (infection-fighting cells) is too low
- Your liver function test results are too high, including bilirubin, AST, or ALT levels (confirm with trial site for exact values)
- Your kidneys are not working well enough, based on a kidney function calculation (confirm with trial site)
- You have a significant amount of protein in your urine
- You are currently pregnant or breastfeeding
- You are able to become pregnant or father a child and are not willing to use effective contraception during the study
- You are breastfeeding and unwilling to stop for the duration of the study
- You are considered to be at increased risk of falling, in the opinion of your healthcare team
- You have received any other cancer treatment, including radiation, within 2 weeks before the start of this study
- You have taken an experimental medication within 4 weeks before starting this study
- You have a history of heart failure and your heart is pumping at 40% or less of its normal capacity
- Stopping your long-acting somatostatin analogue medication (a type of hormone-blocking injection) for 24 hours would be a health risk for you, in your doctor's opinion
- You received a long-acting somatostatin analogue injection within 14 days of starting this study
- You have previously received a high dose of external beam radiation to your kidneys (above 16 Gy) (confirm with trial site)
- You have previously received significant external beam radiation or internal radiation (brachytherapy) to a large portion of your bone marrow (confirm with trial site)
- You have had a serious allergic reaction to medications that are chemically similar to the ones used in this trial (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Early Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Active, Not Recruiting
Phase
Early Phase 1
Sponsor
David Bushnell
Registry
clinicaltrials_gov
Start date
10 November 2023
Est. completion
31 December 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.