Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.

Official Title
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High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: Indium-111 pentetreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy. Patients must have evidence of residual multifocal active tumor. All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved. All patients must have a Karnofsky performance status of at least 60. Patients must be greater than 18 years of age. Patients must have measurable and/or followable disease based on either clinical or radiologic exam. Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial. An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound). If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease. Exclusion Criteria: Karnofsky performance status of 50 or less. Patients who are unable to give informed consent. Patients under 18 years of age. There will be no upper age discrimination. Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period. Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indium-111 pentetreotide<br>4 cycles of 500 mCi treatments every 10-12 weeks | Drug: Indium-111 pentetreotide<br>* 4 cycles of 500 mCi treatments every 10-12 weeks<br>* Other names: NeuroendoMedix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in solid tumor dimensions by CT scan. | Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups. Complete response Partial response No change or stable disease Progression | Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of adverse events | Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria | up to 6 months following the last cycle of therap | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoid, Islet Cell Cancer, Paraganglioma, Pheochromocytoma