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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014