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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442533
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : April 28, 2017
Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Indium-111 pentetreotide Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
Study Start Date : August 2005
Actual Primary Completion Date : August 30, 2014
Actual Study Completion Date : December 29, 2015

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 Name: (Neuroendomedix)

Primary Outcome Measures :
  1. Radiological response [ Time Frame: 3 months after each therapy cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (B-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442533

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United States, Texas
Excel Diagnostic Imaging Clinics
Houston, Texas, United States, 77042
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77225-0269
Sponsors and Collaborators
Radio Isotope Therapy of America
Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
CHI St. Luke's Health, Texas
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Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
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Responsible Party: Ebrahim Delpassand, President and CEO, Radio Isotope Therapy of America Identifier: NCT00442533    
Other Study ID Numbers: 06-2247
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ebrahim Delpassand, Radio Isotope Therapy of America:
Islet Cell Cancer
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue