NCT00006368

Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer

A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with recurrent malignant neoplasms that prove positive for somatostatin receptors. II. Determine the safety and lifetime serious adverse event profile of this regimen in these patients. II. Determine the antitumor effect and the effect of repeated administrations on the renal excretion pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose escalation, multicenter study. Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors. Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1. Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are entered on course I (vertical dose escalation) and courses II, III, and IV (horizontal dose escalation). Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose (MTD) is determined. MTDs are determined for a single course and for 4 courses. The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities. Results of course I determine the dosage of subsequent courses. Patients are evaluated on days 2 and 7, and at weeks 4 and 6, following each injection of yttrium Y 90-SMT 487. Patients are followed at 12 and 18 months and then annually thereafter. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors
• Breast Cancer
• Gastrointestinal Carcinoid Tumor
• Islet Cell Tumor
• Lung Cancer
• Lymphoma
• Melanoma (Skin)
• Neoplastic Syndrome

Interventions

Type	Name	Description
RADIATION	yttrium Y 90-edotreotide

Timeline

• Start date: 1998-01-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2004-04-02
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States