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

Neuroendocrine Tumors Clinical Trial

Official title:

High Dose Indium-111 Pentetreotide Therapy in Somatostatin Receptor Expressing Neuroendocrine Neoplasms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442533
• Other study ID #: 06-2247
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2005
• Est. completion date: December 28, 2015

Study information

• Verified date: March 2023
• Source: Radio Isotope Therapy of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 28, 2015
• Est. primary completion date: August 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (Beta type Human chorionic gonadotropin (ß-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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Indium-111 pentetreotide
4 cycles of 500 mCi treatments every 10-12 weeks

Locations

Country	Name	City	State
United States	Excel Diagnostic Imaging Clinics	Houston	Texas
United States	St. Lukes Episcopal Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Radio Isotope Therapy of America	CHI St. Luke's Health, Texas, Excel Diagnostic Imaging Clinics, Radiomedix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in solid tumor dimensions by CT scan.	Change in diameters of measurable lesions on CT using RECIST. and will be classified into 4 groups.; Complete response; Partial response; No change or stable disease; Progression	Baseline to post treatment CT scan performed 2-4 days after each cycle and 12and 24 weeks after treatments
Secondary	Frequency and severity of adverse events	Frequency and severity of adverse events. All adverse events will be graded using NCI common toxicities criteria	up to 6 months following the last cycle of therap