Cisplatin, Imatinib Mesylate, and Pemetrexed in Malignant Mesothelioma Patients

This study is currently recruiting patients.

Purpose:

Primary Objective:

To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.

Secondary Objectives:

1. To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by:
   1. histologic analysis of biopsy tissue
   2. non-invasive assessments of tumor vascularity performed before, during and after treatment
   3. electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate.
2. To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum.
3. To assess the rate of response to therapy.
4. To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of PDGF-R on malignant mesothelioma tumor cells.
5. To determine the pharmacokinetic interaction between agents in this combination regimen.

Eligibility

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase I Trial of Cisplatin, Pemetrexed, and Imatinib Mesylate in Unresectable or Metastatic Malignant Mesothelioma

Enrollment Size: Both

Gender: 18 Years

Min. Age: N/A

Max. Age:

Location and Contact Information

United States, Texas
U.T.M.D. Anderson Cancer Center, Houston, Texas, 77030, United States
Status: Recruiting
Anne S. Tsao, MD Principal Investigator