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OpenTrials
Completed

NCT Number: NCT00442533

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indium-111 pentetreotide

Drug

4 cycles of 500 mCi treatments every 10-12 weeks

Other names: NeuroendoMedix

Primary outcomes

  1. Change in solid tumor dimensions by CT scan.

    Time frame: Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments

    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

Secondary outcomes

  1. Frequency and severity of adverse events

    Time frame: up to 6 months following the last cycle of therap

    Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria

Sponsors and collaborators

Lead sponsor

Radio Isotope Therapy of America

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2015
First posted
Mar 2, 2007
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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