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Radioisotope Therapy

212Pb-VMT-alpha-NET for Neuroendocrine Tumors

Phase < 1

Waitlist Available

Led By David Bushnell, MD

Research Sponsored by David Bushnell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease not amenable to curative intent treatment and has shown either clinical or radiographic progression on all available therapies known to confer clinical benefit

Prior peptide receptor radionuclide therapy (PRRT)

Must not have

History of congestive heart failure and cardiac ejection fraction ≤ 40%

Total bilirubin ≥ 2.5x institutional upper limit of normal for age and weight

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses the safety of a new drug, testing two doses to determine which is suitable for clinical trials. No therapeutic benefit is expected.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include typical reactions related to radiation therapies such as fatigue, nausea, or localized pain at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have previously undergone PRRT treatment.

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I can understand and agree to participate in the study.

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I am between 18 and 80 years old.

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I do not have any other cancer that needs immediate treatment.

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My cancer is a grade 1 or 2 neuroendocrine tumor.

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My PET/CT scan shows SSTR positive tumor sites.

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I am mostly able to carry out my daily activities.

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I have a tumor larger than 1.0 cm that can be measured on a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My bilirubin levels are more than 2.5 times the normal range for my age and weight.

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I've had radiation therapy that affected 25% of my bone marrow.

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My kidneys have received more than 16 Gy of radiation.

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My kidney function is reduced, with an eGFR below 50.

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I am breastfeeding and choose not to stop.

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I am allergic to certain cancer imaging or treatment drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine recommended therapeutic dose of [212Pb] VMT-α-NET

Secondary study objectives

Maximum tolerated radiation dose for kidneys

Objective Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 16Eligibility criteria met