Investigational New Drugs

, Volume 20, Issue 4, pp 389–393 | Cite as

A Phase II Study of Thalidomide in Advanced Metastatic Renal Cell Carcinoma

  • David R. Minor
  • Dana Monroe
  • Lisa A. Damico
  • Gloria Meng
  • Uma Suryadevara
  • Laurence Elias
Article

Abstract

Objectives: To evaluate the toxicityand activity of thalidomide in patientswith advanced metastatic renal cell cancerand to measure changes of one angiogenicfactor, vascular endothelial growth factor(VEGF)165, with therapy.

Patients and methods: 29 patients were enrolled on astudy of thalidomide using an intra-patientdose escalation schedule. Patients beganthalidomide at 400 mg/d and escalated astolerated to 1200 mg/d by day 54.Fifty-nine per cent of patients had hadprevious therapy with IL-2 and 52% wereperformance status 2 or 3. Systemic plasmaVEGF165 levels were measured by dualmonoclonal ELISA in 8 patients.

Results: 24 patients were evaluable forresponse with one partial response of 11months duration of a patient with hepaticand pulmonary metastases (4%), one minorresponse, and 2 patients stable for over 6months. Somnolence and constipation wereprominent toxicities and most patientscould not tolerate the 1200 mg/day doselevel. Systemic plasma VEGF165 levels didnot change with therapy.

Conclusion: These results are consistent with a lowlevel of activity of thalidomide in renalcell carcinoma. Administration of dosesover 800 mg/day was difficult to achieve inthis patient population, however lowerdoses were practical. The dose-responserelationship, if any, of thalidomide forrenal cell carcinoma is unclear.

angiogenesis renal cell carcinoma thalidomide Thalomid vascular endothelial growth factor VEGF 

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Copyright information

© Kluwer Academic Publishers 2002

Authors and Affiliations

  • David R. Minor
    • 1
    • 2
    • 3
  • Dana Monroe
    • 1
    • 2
    • 3
  • Lisa A. Damico
    • 1
    • 2
    • 3
  • Gloria Meng
    • 1
    • 2
    • 3
  • Uma Suryadevara
    • 1
    • 2
    • 3
  • Laurence Elias
    • 1
    • 2
    • 3
  1. 1.California Kidney Cancer CenterCalifornia Pacific Medical CenterSan Francisco
  2. 2.Genentech CorporationSouth San Francisco
  3. 3.The Department of Medicine and Cancer Research and Treatment CenterUniversity of New Mexico Medical CenterAlbuquerqueUSA

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