212Pb-VMT-alpha-NET for Neuroendocrine Tumors

Recruiting in Palo Alto (17 mi)

Overseen byDavid Bushnell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: David Bushnell

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.

Eligibility Criteria

This trial is for adults aged 18-80 with well-differentiated neuroendocrine tumors who've had prior treatments and show no immediate response. They must be willing to follow the study's procedures, have a good performance status, not have other active cancers needing treatment, and agree to use effective contraception.

Inclusion Criteria

My condition cannot be cured and has worsened despite all known beneficial treatments.

I have previously undergone PRRT treatment.

Stated willingness to comply with all study procedures and availability for duration of study

+9 more

Exclusion Criteria

I haven't taken any experimental drugs in the last 4 weeks.

I have a history of heart failure and my heart's pumping ability is reduced.

I haven't had any cancer treatment, including radiation, in the last 2 weeks.

+16 more

Participant Groups

The safety of two treatments using a radioactive substance called [212Pb] VMT-α-NET is being tested. The goal is to find the right dose for future trials. This study focuses on safety rather than therapeutic benefit.

5Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment2 Interventions

If the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy.

Group II: Cohort 3Experimental Treatment2 Interventions

If the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy.

Group III: Cohort 2Experimental Treatment2 Interventions

If the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy.

Group IV: Cohort 1Experimental Treatment2 Interventions

This is the starting dose level for participants. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy.

Group V: -1 Dose LevelExperimental Treatment2 Interventions

This dose level is used if the starting dose level is deemed to have unacceptable toxicity. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy.