Study on New Treatment for Advanced Gastrointestinal Neuroendocrine Tumors and Pheochromocytoma/Paraganglioma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06427798
This clinical trial is testing a new drug, [212Pb]VMT-alpha-NET, designed to target and treat advanced gastrointestinal neuroendocrine tumors and pheochromocytoma/paraganglioma that cannot be removed by surgery. The drug combines a protein that binds to tumor cells with a radioactive component to kill them.
Patient Parameters
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Program Overview
The study focuses on a new treatment for certain types of tumors that have high levels of a protein called somatostatin receptors (SSTR). These tumors include gastrointestinal neuroendocrine tumors (GI NET) and pheochromocytoma/paragangliomas (PPGL). The treatment uses a drug called [212Pb]VMT-alpha-NET, which targets these receptors and delivers radiation directly to the cancer cells to destroy them. The trial aims to determine the safety and effectiveness of this treatment in adults with these advanced tumors.
Description
This study is testing a new treatment for advanced gastrointestinal neuroendocrine tumors (GI NET) and pheochromocytoma/paraganglioma (PPGL) that cannot be surgically removed. The treatment involves a drug called [212Pb]VMT-alpha-NET, which targets a protein on the surface of these tumors and delivers radiation to kill the cancer cells.
The study is divided into two phases. Phase I will determine the safest dose of the drug, while Phase II will evaluate how well the drug works in shrinking tumors. Participants will receive the drug through an infusion every eight weeks for a total of four treatments. Some participants will also receive a related drug, [203Pb]VMT-alpha-NET, to help track where the treatment goes in the body using special scans.
Participants will be closely monitored with regular blood tests, scans, and follow-up visits to assess the treatment's safety and effectiveness. The study will continue to follow participants for up to 10 years to monitor their health and survival.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older with advanced gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paraganglioma (PPGL) that cannot be removed by surgery.
- Must have received at least one prior treatment with a similar type of therapy.
- Must have at least one tumor that can be measured by scans.
- Tumors must show high levels of somatostatin receptors (SSTR) on scans.
- Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Participants with treated brain metastases are eligible if scans show no progression.
- Participants with HIV, hepatitis B, or hepatitis C must have these conditions under control with appropriate treatments.
- Must agree to use effective contraception during the study and for six months after the last dose.
- Must be willing to sign an informed consent document.
Exclusion Criteria
- History of allergic reactions to similar drugs.
- Positive pregnancy test in women of childbearing potential.
- Abnormal heart rhythm as shown on an EKG.
- Active or untreated secondary cancer, except for certain non-threatening types.
- Uncontrolled medical conditions that could increase the risk of participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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