Clinical Trials Directory

Trials / Terminated

TerminatedNCT00002947

Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

A Phase I Study of [111In-DTPA-D-Phe]-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Yale University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD), toxic effects, and the preliminary antitumor activity of indium In 111 pentetreotide. OUTLINE: This is a dose escalation study. Patients receive indium In III pentetreotide (OctreoScan) IV on day 1. Imaging is conducted on days 3 and 6. Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Patients are followed every 3 months for the first year, then every 6 months thereafter. PROJECTED ACCRUAL: Up to 35 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
RADIATIONindium In 111 pentetreotide

Timeline

Start date
1996-10-01
Primary completion
2004-08-01
Completion
2004-08-01
First posted
2004-03-26
Last updated
2014-07-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00002947. Inclusion in this directory is not an endorsement.