Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Pheochromocytoma

Paraganglioma

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Paragangliomas 1

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

3-Iodobenzylguanidine

Enzyme Inhibitors

Radiopharmaceuticals

Subjects will receive a dosimetry dose of AZEDRA and will undergo 3 whole body scans. If the scans indicate tumor avidity for AZEDRA, the subjects will receive up to 2 therapeutic doses of AZEDRA each at 500 mCi (or 8 mCi/kg, for subjects weighing 62.5 kg or less) approximately 90 days apart.

Ultratrace Iobenguane I131

The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).

MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect additional safety data.

Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Expanded Access Program of AZEDRA (Ultratrace Iobenguane I131) in Subjects With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma: A Sub-study of Protocol MIP-IB12B

Molecular Insight Pharmaceuticals, Inc.

Gastro-enteropancreatic Neuroendocrine Tumor

Lutetium Lu 177 dotatate

Combined treatment with Lutathera® and Azedra® Administered amounts of each drug are based on imaging and radiation dose constraints to the kidneys and the bone marrow. The drug administration is individualized to each participant.

Single agent Lutathera® administered per standard of care: 200 millicuries of drug every 8 weeks for a total of 4 doses.

Lutathera

Azedra

David Bushnell, M.D.

This study is designed to identify the best tolerated doses of Lutathera® and Azedra® when co-administered to treat midgut neuroendocrine tumors. These drugs are radioactive drugs, known as radionuclide therapy, and are both approved in the treatment of midgut neuroendocrine tumor as single agents (not together). Currently, the safest and best tolerated doses of these drugs (when combined) is unknown. That is the purpose of this clinical trial.

Azedra and Lutatheraare are FDA-approved radioactive drugs designed to treat specific tumor cells. These drugs are a combination of the radiation (131-Iodine, 177-lutetium) and a protein that targets the tumor cell (MIBG or DOTATATE). 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.

Azedra and Lutathera 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 DOTATATE 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 DOTATATE. For these people, this means treating only with Azedra or Lutathera 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 Azedra and Lutathera.

After receiving a standard treatment of Lutathera, participants are asked to undergo imaging to verify they have both MIBG and DOTATATE tumor types:

* participants are given a tracer dose of Azedra
* a special camera (SPECT/CT) collects images (scans)
* imaging (scans) are done over 4 calendar days
* blood samples are taken at that time, too, to measure the circulating amount of tracer doses

If the scans show a participant does not have both MIBG and DOTATATE receptors, they continue with standard therapy (Lutathera only). Participants are asked to still undergo study assessments to provide a comparison group.

If the scans show a participant has both MIBG and DOTATATE receptors, combined therapy is administered:

* a customized dose of Lutathera is given on day 1 of a treatment cycle. This is given outpatient.
* a customized dose of Azedra 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 Lutathera and Azedra 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.

Participants who do not meet eligibility criteria for the combined therapy will be asked to participate in the active comparator, which is single agent Lutathera administered as per FDA guidelines.

A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors

A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors

Participants must opt in to data sharing. For those that do, imaging, adverse event, and treatment data will be provided.

MTD will be determined by incidence of renal AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

MTD will be determined by incidence of hematologic AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Objective response rate, measured using standardized RECIST criteria, is a reflection of complete tumor response and partial tumor response when obtained at 6 months and 12 months post-treatment.

Determine tumor size and response using RECIST 1.1 criteria in patients treated with the combined regimen

Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (v5)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma	NCT02961491	Pheochromocytom... Paraganglioma	Ultratrace Iobe...	12 Years -	Molecular Insight Pharmaceuticals, Inc.
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors	NCT04614766	Gastro-enteropa... Neuroendocrine ...	Lutathera Azedra	18 Years - 80 Years	University of Iowa

Spots Global Cancer Trial Database for azedra

Every month we try and update this database with for azedra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azedra

Every month we try and update this database with for azedra cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azedra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.