What side effects are associated with this type of intervention?

The most common treatments for neuroendocrine tumors using targeted radiation therapy via somatostatin receptor binding, such as 177Lu-DOTATATE, have several known side effects. These include nausea, which is often related to the amino acid infusions used to protect the kidneys, and hematologic toxicities like thrombocytopenia, lymphopenia, anemia, and leukopenia. These blood-related side effects are generally mild but can occasionally be severe. Other potential side effects include nephrotoxicity, myelodysplastic syndrome, and, rarely, acute myeloid leukemia. Overall, these treatments are well-tolerated, but careful monitoring is essential to manage and mitigate adverse effects.

What prior FDA approvals exist?

The FDA has approved 177Lu-Dotatate for the treatment of somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors (NETs) in adults. This radiopharmaceutical therapy, approved in January 2018, targets somatostatin receptors on tumor cells to deliver targeted radiation, significantly improving progression-free survival and quality of life. Another similar therapy is 131I-meta-iodobenzylguanidine (131I-MIBG) for metastatic carcinoid tumors, although specific FDA approval details for this therapy are not provided.

What other types of research exist?

Promising alternatives to 212Pb-DOTAMTATE for NET patients include 177Lu-DOTATATE and 68Ga-DOTATOC. 177Lu-DOTATATE has demonstrated significant benefits in progression-free survival and quality of life, with manageable adverse effects. 68Ga-DOTATOC is effective for imaging and clinical management of NETs, aiding in precise treatment planning.

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Radioisotope Therapy

AlphaMedix for Neuroendocrine Cancer (ALPHAMEDIX02 Trial)

Phase 2

Waitlist Available

Research Sponsored by Radiomedix, Inc.

Eligibility Criteria Checklist

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

Must have

Subjects must have received and progressed following somatostatin analog administration

Documented progression of disease following previous therapy within 12 months prior to enrollment and the presence of at least 1 site of measurable disease per RECIST 1.1

Must not have

Known brain metastases, unless these metastases have been treated and/or stable for 6 months prior to enrollment

History of myelodysplastic syndrome (MDS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after last dose administration

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a radioactive drug called 212Pb-DOTAMTATE in adults with neuroendocrine tumors. It aims to see how well it works in patients who are either new to or have previously received similar treatments. The drug targets and kills cancer cells using radiation.

Who is the study for?

Adults over 18 with advanced neuroendocrine tumors (NET) that can't be removed by surgery or have spread, and who've had disease progression after previous treatments. Participants must have a life expectancy of at least 12 weeks, adequate organ function, and confirmed somatostatin receptors on their tumors. Pregnant women, those with certain heart conditions or infections like HIV/Hepatitis B/C, recent recipients of similar therapies, or individuals with uncontrolled health issues are excluded.

What is being tested?

The trial is testing AlphaMedix (212Pb-DOTAMTATE), a targeted radiotherapy for NET patients who either haven't received peptide receptor radionuclide therapy (PRRT naive) or have previously undergone PRRT. It's a Phase 2 study to see how well this treatment works in controlling the disease.

What are the potential side effects?

While specific side effects aren't listed here, typical ones from radiotherapies like AlphaMedix may include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation due to radiation exposure could also occur.

Eligibility Criteria

Inclusion Criteria

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

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My condition worsened after treatment with somatostatin analogs.

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My cancer has worsened within the last year and can be measured.

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My recent blood tests show my organs and bone marrow are working well.

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My cancer shows high activity on specific scans compared to normal liver.

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My cancer has worsened within the last year and can be measured.

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My cancer shows high activity on specific scans compared to normal liver.

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I am able to get out of my bed or chair and move around.

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My cancer has visible signs on scans that meet specific criteria.

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I am 18 or older with a NET that cannot be surgically removed or has spread.

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My condition worsened after receiving somatostatin analog treatment.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

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

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My brain metastases have been stable or treated for at least 6 months.

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I have a history of myelodysplastic syndrome.

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I have had whole-body radiotherapy or specific targeted radiation therapy.

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I am not pregnant or breastfeeding.

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I haven't had liver-targeted radiation in the last 4 months or non-radiation liver therapy in the last 6 months.

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My diabetes is not under control, with an A1C level over 10.0.

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I haven't used any somatostatin drugs like Sandostatin in the last 28 days.

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My doctor believes surgery could potentially cure my condition.

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My tests show a blockage in my kidneys.

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My heart condition is not under control.

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I do not have active HIV or hepatitis B/C, or if I had, it is now cured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months after last dose administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months after last dose administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after last dose administration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0

Secondary study objectives

Measurement of Overall Survival (OS)

Measurement of Time to Tumor Progression (TTP)

Measurement of the Median Progression free survival (mPFS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pb212-DOTAMTATEExperimental Treatment1 Intervention

investigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2)

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neuroendocrine Tumors (NETs) like 212Pb-DOTAMTATE, 177Lu-DOTATATE, and 90Y-DOTA-lanreotide utilize targeted radiation therapy via somatostatin receptor binding. These therapies exploit the overexpression of somatostatin receptors on NET cells to deliver radioactive isotopes directly to the tumor, thereby minimizing collateral damage to healthy tissues and enhancing treatment efficacy. This targeted approach is significant for NET patients as it underscores the importance of receptor expression in selecting the most effective therapy and improving clinical outcomes.

In- and Y-DOTA-lanreotide: results and implications of the MAURITIUS trial.