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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Maximum feasible dose defined as the highest dose studied for which the incidence of DLT is less than 33% or the highest safe dose in our study, limited to a maximum MFD dose of 40 mg/hr [ Time Frame: 4 weeks ]

Original Primary Outcome:

Current Secondary Outcome: Pharmacokinetics of EMD 121974 [ Time Frame: Up to 8 weeks ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 10, 2004
Date Started: December 2003
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013