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

• Status: Completed
• Trial end date: 2015-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radio Isotope Therapy of America
• Collaborators: CHI St. Luke's Health, Texas; Excel Diagnostic Imaging Clinics; RadioMedix; Radiomedix, Inc.
• Treatments: Somatostatin

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.