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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Excel Diagnostic Imaging Clinics
RadioMedix
St. Luke's Medical Center, Texas
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America
ClinicalTrials.gov Identifier:
NCT00442533
First received: March 1, 2007
Last updated: April 2, 2014
Last verified: April 2014
  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
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Resource links provided by NLM:


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: 200
Study Start Date: August 2005
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 111In pentetreotide Drug: High Dose Indium-111 pentetreotide
3 cycles of 500 mCi treatments every 10-12 weeks
Other Name: (Neuroendomedix)

  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

Locations
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
St. Luke's Medical Center, Texas
Investigators
Principal Investigator: Ebrahim Delpassand, M.D. RITA Foundation
  More Information

No publications provided

Responsible Party: Ebrahim Delpassand, President and CEO, Radio Isotope Therapy of America
ClinicalTrials.gov Identifier: NCT00442533     History of Changes
Other Study ID Numbers: 06-2247
Study First Received: March 1, 2007
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Radio Isotope Therapy of America:
Carcinoid
Islet Cell Cancer
Paraganglioma
Pheochromocytoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 20, 2014