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Neuroendocrine Tumor

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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

Neoplastic Processes

Somatostatin

Hormones

Hormone Antagonists

Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of

* renal toxicity
* loss of patient transferability or
* denial of further treatment.

DOTA-TOC Treatment

Martin A Walter, MD, Dr.

The investigators aim to explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). \[90Y-DOTA\]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009).

Study Aim: To explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer.

Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.

Study Type: Clinical phase II, single-center, open-label trial

Patients: 1500 patients

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
DOTA-TOC in Metastasized Neuroendocrine Tumors	NCT00978211	Neuroendocrine ...	DOTA-TOC Treatm...	-	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for dotatoc

Every month we try and update this database with for dotatoc 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 dotatoc

Every month we try and update this database with for dotatoc 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 dotatoc 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.