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Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
This study is currently recruiting participants.
Verified by Radio Isotope Therapy of America, May 2008
Sponsors and Collaborators: Radio Isotope Therapy of America
Excel Diagnostic Imaging Clinics
RadioMedix
St. Luke's Episcopal Hospital, Texas
Information provided by: Radio Isotope Therapy of America
ClinicalTrials.gov Identifier: NCT00442533
  Purpose

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


Condition Intervention Phase
Neuroendocrine Tumors
Drug: High Dose Indium-111 pentetreotide (Neuroendomedix)
Phase II
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Somatostatin Pentetreotide Indium in 111 pentetreotide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Further study details as provided by Radio Isotope Therapy of America:

Primary Outcome Measures:
  • Radiological response [ Time Frame: 3 months after each therapy cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2005
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: High Dose Indium-111 pentetreotide (Neuroendomedix)
    3 cycles of 500 mCi treatments every 10-12 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442533

Contacts
Contact: Christiane Assir 713-341-3239 cassir@exceldiagnostics.com

Locations
United States, Texas
Excel Diagnostic Imaging Clinics Recruiting
Houston, Texas, United States, 77042
St. Lukes Episcopal Hospital Recruiting
Houston, Texas, United States, 77225-0269
Sponsors and Collaborators
Radio Isotope Therapy of America
Excel Diagnostic Imaging Clinics
RadioMedix
St. Luke's Episcopal Hospital, Texas
Investigators
Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
  More Information

Responsible Party: Rita Foundation ( Ebrahim Delpassand )
Study ID Numbers: 06-2247
Study First Received: March 1, 2007
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00442533  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Somatostatin
Neuroendocrine Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009