Overview

This trial is active, not recruiting.

Condition neuroendocrine tumors
Treatment high dose indium-111 pentetreotide
Phase phase 2/phase 3
Sponsor Radio Isotope Therapy of America
Collaborator Excel Diagnostic Imaging Clinics
Start date August 2005
End date August 2014
Trial size 200 participants
Trial identifier NCT00442533, 06-2247

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
high dose indium-111 pentetreotide (Neuroendomedix)
3 cycles of 500 mCi treatments every 10-12 weeks

Primary Outcomes

Measure
Radiological response
time frame: 3 months after each therapy cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.
Principal investigator Ebrahim Delpassand, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Radio Isotope Therapy of America.