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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.
 
ClinicalTrials.gov Identifier: NCT00442533
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America

Tracking Information
First Submitted Date  ICMJE March 1, 2007
First Posted Date  ICMJE March 2, 2007
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE August 2005
Actual Primary Completion Date August 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
Radiological response [ Time Frame: 3 months after each therapy cycle ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00442533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
Official Title  ICMJE High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Other Name: (Neuroendomedix)
Study Arms  ICMJE Experimental: Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks
Intervention: Drug: Indium-111 pentetreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2011)
200
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 29, 2015
Actual Primary Completion Date August 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442533
Other Study ID Numbers  ICMJE 06-2247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ebrahim Delpassand, Radio Isotope Therapy of America
Study Sponsor  ICMJE Radio Isotope Therapy of America
Collaborators  ICMJE
  • Excel Diagnostic Imaging Clinics
  • Radiomedix, Inc.
  • CHI St. Luke's Health, Texas
Investigators  ICMJE
Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
PRS Account Radio Isotope Therapy of America
Verification Date April 2017

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