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Radioisotope Therapy

212Pb-VMT-alpha-NET for Neuroendocrine Tumors

Q: Would I be eligible to become a participant in this medical trial?

To be eligible to participate, individuals must have a <a href="https://www.withpower.com/clinical-trials/neuroendocrine-tumor">neuroendocrine tumor</a> and lie in the age range of 18-80. This trial seeks 24 participants in total.

Q: Are any more participants needed for this research endeavor?

Affirmative. According to the information on clinicaltrials.gov, this medical trial is actively recruiting patients since its posting date of November 10th 2023 and most recently updated record from November 20th 2023. Currently, 24 participants are being sought out across a single site.

Q: Does the research accept participants aged under eighty?

The criteria for this clinical trial necessitates that interested individuals are aged between 18 and 80. With respect to minors, 377 trials exist while the over 65 demographic has 4466 studies available.

Q: What is the cap on enrollment for this clinical trial?

Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants that began November 10th 2023 and was last updated on the twentieth of that same month. The study requires 24 individuals from one center/site.

Phase < 1

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post-treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Maximum tolerated radiation dose for kidneys

Objective Response Rate (ORR)

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 / 9Eligibility criteria met

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Who is running the clinical trial?

David BushnellLead Sponsor

3 Previous Clinical Trials

72 Total Patients Enrolled

3 Trials studying Neuroendocrine Tumors

72 Patients Enrolled for Neuroendocrine Tumors

Holden Comprehensive Cancer CenterOTHER

26 Previous Clinical Trials

753 Total Patients Enrolled

5 Trials studying Neuroendocrine Tumors

93 Patients Enrolled for Neuroendocrine Tumors

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,830 Total Patients Enrolled

78 Trials studying Neuroendocrine Tumors

43,599 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to become a participant in this medical trial?

"To be eligible to participate, individuals must have a neuroendocrine tumor and lie in the age range of 18-80. This trial seeks 24 participants in total."

Answered by AI

Are any more participants needed for this research endeavor?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is actively recruiting patients since its posting date of November 10th 2023 and most recently updated record from November 20th 2023. Currently, 24 participants are being sought out across a single site."

Answered by AI

Does the research accept participants aged under eighty?

"The criteria for this clinical trial necessitates that interested individuals are aged between 18 and 80. With respect to minors, 377 trials exist while the over 65 demographic has 4466 studies available."

Answered by AI

What is the cap on enrollment for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this experiment is currently recruiting participants that began November 10th 2023 and was last updated on the twentieth of that same month. The study requires 24 individuals from one center/site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors

David Bushnell 2023. "A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148636.

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