Status:
COMPLETED
Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors
Lead Sponsor:
Radio Isotope Therapy of America
Collaborating Sponsors:
Excel Diagnostic Imaging Clinics
Radiomedix, Inc.
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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 (Beta type Human chorionic gonadotropin (β-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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00442533
Start Date
August 1 2005
End Date
December 28 2015
Last Update
April 3 2023
Active Locations (2)
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1
Excel Diagnostic Imaging Clinics
Houston, Texas, United States, 77042
2
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77225-0269