Safety And Efficacy Study Of In-111 Pentetreotide To Treat Neuroendocrine Tumors

Study Overview

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

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

N/A

Neuroendocrine Tumors

DRUG: Indium-111 pentetreotide

06-2247

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-03-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-03-28
First Submitted that Met QC Criteria 2007-03-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-04-03
First Posted (ACTUAL) 2007-03-02	Results First Posted N/A	Last Verified 2023-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Indium-111 pentetreotide 4 cycles of 500 mCi treatments every 10-12 weeks	DRUG: Indium-111 pentetreotide 4 cycles of 500 mCi treatments every 10-12 weeks

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Indium-111 pentetreotide

4 cycles of 500 mCi treatments every 10-12 weeks

DRUG: Indium-111 pentetreotide

4 cycles of 500 mCi treatments every 10-12 weeks

Primary Outcome Measures	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. 1. Complete response 2. Partial response 3. No change or stable disease 4. Progression	Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
CHI St. Luke's Health, Texas

Investigators

PRINCIPAL_INVESTIGATOR: Ebrahim Delpassand, M.D., RITA Foundation

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record