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

Radio Isotope Therapy of America

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: Indium-111 pentetreotide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00442533

06-2247

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Indium-111 pentetreotide

Experimental group

Description:

4 cycles of 500 mCi treatments every 10-12 weeks

Treatment:

Drug: Indium-111 pentetreotide