Neoplasms

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Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

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Antineoplastic Agents, Hormonal

Radiopharmaceuticals

Phenylalanine

Subject will be administered 2.96 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.33 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.7 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.17 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.44 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Subject will be administered 5.18 gigabecquerels of \[90\]Y-DOTATOC intra-aterially to the liver

Intra-arterial infusion to the liver of \[90\]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.

[90]Y-DOTATOC

M. S O'Dorisio, MD, PhD

Sandeep Laroia, MD

This is a safety study to determine the phase 1 starting dose of \[90\]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

\[90\]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the malignant cell.

This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly to the liver is safe for patients with neuroendocrine tumors whose disease has spread to their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn what the maximum safe dose is and what the side effects are related to that dose.

This is a sequential early phase 1 study using Storer's phase 1 design B.

Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases

Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.

Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes

Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count

Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count

Determine the distribution of 90Y-DOTATOC using post-treatment imaging

National Institutes of Health (NIH)

Holden Comprehensive Cancer Center

National Cancer Institute (NCI)

Sandeep Laroia

Associate Professor

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

3-Iodobenzylguanidine

This is the initial treatment arm. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 150 centiGray (cGy) Radiation exposure to the kidneys is limited to 1900 centiGray (cGy)

This treatment arm is opened if Cohort 1 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 200 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)

This treatment arm is opened if Cohort 2 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 250 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)

This treatment arm is opened if Cohort 1 is not tolerated.

131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 100 centiGray (cGy) Radiation exposure to the kidneys is limited to 1500 centiGray (cGy)

No further dose evaluations are done after this cohort is completed.

This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.

131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 200 centiGray (cGy) Radiation exposure to the kidneys is limited to 1500 centiGray (cGy)

No further dose evaluations are done after this cohort is completed.

This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.

131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 100 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)

No further dose evaluations are done after this cohort is completed.

This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 3.

131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 250 centiGray (cGy) Radiation exposure to the kidneys is limited to 1900 centiGray (cGy)

No further dose evaluations are done after this cohort is completed.

This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.

131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.

Radiation exposure to the bone marrow is limited to 150 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)

No further dose evaluations are done after this cohort is completed.

Peptide receptor radiotherapy (PRRT) using Yttrium-90 as the active radionuclide. For intravenous administration only.

90Y-DOTA-3-Tyr-Octreotide

Peptide receptor radiotherapy (PRRT) using Iodine-131 as the active radionuclide. For intravenous administration only.

131I-MIBG

David Bushnell, MD

This study is designed to identify the best tolerated doses of \[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC when co-administered to treat midgut neuroendocrine tumors. These drugs (131I-MIBG, 90Y-DOTATOC) are radioactive drugs, known as radionuclide therapy. Currently, the safest and best tolerated doses of these drugs (when combined together) is unknown.

\[131\]Iodine-MIBG and \[90\]Yttrium-DOTATOC are radioactive drugs designed to treat specific tumor cells. These drugs are a combination of the radiation (131-Iodine, 90-Yttrium) and a protein that targets the tumor cell (MIBG or DOTATOC). Because these proteins are attracted to, and stick to, the tumor, the radiation is centered in the tumors. This kills more tumor cells and minimizes radiation-damage to healthy tissues, like the heart and lungs.

Two organs still absorb some of the radiation, though: bone marrow and the kidney. These organs limit how much radiation can be given to tumors, but we don't know how much radiation is too much. Too much radiation to bone marrow can result in anemia. Too much radiation to the kidneys can result in kidney failure. From prior radiation therapies, we have a general idea of how much radiation we can give safely.

131I-MIBG and 90Y-DOTATOC have never been given together. We want to give them together because many times, tumors are actually groups of different types of cells. This means, not all the cells respond to therapy the same way. If some tumor cells survive therapy, the tumor will continue to grow and eventually come back. We know some mid-gut neuroendocrine tumors (NETs) have targets for DOTATOC and some other mid-gut NETs have targets for MIBG. We also have now identified that some people with mid-gut NETs have different tumors: some with targets for MIBG and some with targets for DOTATOC. For these people, this means treating only with 131I-MIBG or 90Y-DOTATOC will not be enough to treat their cancer. They need both radioactive drugs.

Because we are combining these radioactive drugs, this study is known as a first-in-man study. We are also using a special imaging to help us estimate the radiation dose to the bone marrow and to the kidneys. This is what decides the final dose of 131I-MIBG and 90Y-DOTATOC.

Before receiving therapy, participants will be asked to undergo imaging to verify they have both MIBG and DOTATOC tumor types:

* participants are given very small doses of radioactive drugs
* a special camera (SPECT/CT) collects images (scans)
* imaging (scans) are done over 3 calendar days
* blood samples are taken at that time, too, to measure the circulating amount of tracer doses

If the scans show a participant has both MIBG and DOTATOC tumors, therapy is given:

* a customized dose of 90Y-DOTATOC is given on day 1 of a treatment cycle. This is given outpatient.
* a customized dose of 131I-MIBG is given on day 2 of a treatment cycle. This is given inpatient (admitted to the hospital).
* participants are monitored through blood tests to identify the side effects of therapy.

Each participant can have up to 2 cycles of therapy. The cycles are 12 weeks apart.

The doses for 90Y-DOTATOC and 131I-MIBG are decided based on radiation to the bone marrow and radiation to the kidney. Doses are decided by how well other participants have done on this study.

Participants have life long follow-up for this study. This is very important, because a study like this has not been done.

Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors

Phase 1 Trial Using 131I MIBG and 90Y DOTATOC in a Dosimetrically Determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors.

Information will be distributed via clinicaltrials.gov and shared as per the filed NIH data sharing plan

Evaluate renal toxicity using eGFR measurement

Evaluate renal toxicity using urine protein measurement

Evaluate bone marrow toxicity using platelet counts

Evaluate bone marrow toxicity using absolute neutrophil count

From day 1 of therapy to documented disease progression in CT or MRI as per RECIST criteria

From start of treatment (cycle 1, day 1) until the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases	NCT03724409	Neuroendocrine ...	[90]Y-DOTATOC	18 Years -	University of Iowa
Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors	NCT03044977	Neuroendocrine ... Neuroendocrine ...	90Y-DOTA-3-Tyr-... 131I-MIBG	18 Years - 80 Years	University of Iowa

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