Phase II trial of imatinib (Gleevec) in patients with metastatic renal cell carcinoma

Jacqueline Vuky1, Christina Isacson, Mehran Fotoohi

  • 1Section of Hematology/Oncology, Virginia Mason Hospital and Department of Medicine, University of Washington, Seattle, WA, USA. jacqueline.vuky@vmmc.org

Investigational New Drugs
|December 29, 2005
PubMed

Insights

This Phase II trial investigated imatinib for metastatic renal cell carcinoma (RCC). No patients achieved a response, indicating limited efficacy for this treatment in advanced RCC.

Area of Science:

  • Oncology
  • Clinical Pharmacology

Background:

  • Metastatic renal cell carcinoma (RCC) presents a significant clinical challenge.
  • Targeted therapies are crucial for improving outcomes in advanced RCC.

Purpose of the Study:

  • To evaluate the efficacy and safety of imatinib in patients with metastatic renal cell carcinoma.
  • To assess KIT (CD117) protein expression in RCC tumors treated with imatinib.

Main Methods:

  • A Phase II clinical trial was conducted involving 14 patients with metastatic RCC.
  • Patients received oral imatinib 400 mg twice daily.
  • Tumor samples were analyzed for KIT protein expression using immunohistochemistry (IHC).

Main Results:

  • No complete or partial responses were observed in the 12 evaluable patients.
  • The most frequent toxicities included Grade II/III nausea (28%) and Grade II renal insufficiency (14%).
  • Only one tumor (7%) showed strong, diffuse KIT protein expression; others were negative.

Conclusions:

  • Imatinib demonstrated limited efficacy as a treatment for metastatic renal cell carcinoma in this study.
  • The observed toxicities were manageable.
  • Further research may be needed to identify predictive biomarkers for imatinib response in RCC.