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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442533
First Posted: March 2, 2007
Last Update Posted: April 28, 2017
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.
Collaborators:
Excel Diagnostic Imaging Clinics
RadioMedix
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America
March 1, 2007
March 2, 2007
April 28, 2017
August 2005
August 30, 2014   (Final data collection date for primary outcome measure)
Radiological response [ Time Frame: 3 months after each therapy cycle ]
Not Provided
Complete list of historical versions of study NCT00442533 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neuroendocrine Tumors
Drug: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Other Name: (Neuroendomedix)
Experimental: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Intervention: Drug: Indium-111 pentetreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 29, 2015
August 30, 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00442533
06-2247
Yes
Not Provided
Plan to Share IPD: Undecided
Ebrahim Delpassand, Radio Isotope Therapy of America
Radio Isotope Therapy of America
  • Excel Diagnostic Imaging Clinics
  • RadioMedix
  • CHI St. Luke's Health, Texas
Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
Radio Isotope Therapy of America
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP