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

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

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

Study Overview

• Status: Completed
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: Indium-111 pentetreotide

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Excel Diagnostic Imaging Clinics
    • Houston, Texas, United States, 77225-0269
      • St. Lukes Episcopal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: NeuroendoMedix

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radio Isotope Therapy of America
• Collaborators: Radiomedix, Inc.; Excel Diagnostic Imaging Clinics; CHI St. Luke's Health, Texas
• Investigators: Principal Investigator: Ebrahim Delpassand, M.D., RITA Foundation

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): August 30, 2014
• Study Completion (Actual): December 28, 2015

Study Registration Dates

• First Submitted: March 1, 2007
• First Submitted That Met QC Criteria: March 1, 2007
• First Posted (Estimate): March 2, 2007

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pheochromocytoma; Carcinoid; Paraganglioma; Islet Cell Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: 06-2247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED