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

2014-08-27 03:54:37 | BioPortfolio

Summary

RATIONALE: Cilengitide (EMD 121974) may stop the growth of cancer cells by stopping blood flow to the cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of EMD 121974 in treating patients with solid tumors or lymphoma.

Description

OBJECTIVES:

Primary

- 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.

- Determine the safety and tolerability of this drug in these patients.

Secondary

- Determine the pharmacokinetics of this drug in these patients.

- 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.

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study within 5.3-13 months.

Study Design

Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

cilengitide

Location

University of Chicago Cancer Research Center
Chicago
Illinois
United States
60637-1470

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:37-0400

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Medical and Biotech [MESH] Definitions

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Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

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