Clinical Trials Directory

Trials / Completed

CompletedNCT00077155

Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma

A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
45 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma. Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer

Detailed description

PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma. II. Determine the safety and tolerability of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of this drug in these patients. II. Determine the antineoplastic activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Conditions

Interventions

TypeNameDescription
DRUGcilengitide

Timeline

Start date
2003-12-01
Primary completion
2010-06-01
First posted
2004-02-11
Last updated
2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00077155. Inclusion in this directory is not an endorsement.