A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
I. Determine the antitumor cytostatic activity of thalidomide, as measured by the
probability of progression-free survival (PFS) for at least 6 months, in patients with
recurrent or persistent uterine leiomyosarcoma.
II. Determine the nature and degree of the toxicity of this drug in these patients.
III. Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of PFS and overall survival of patients treated with this drug.
V. Determine the effect of this drug on initial performance status in these patients.
VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors
(vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine
of these patients.
VII. Assess the association of endogenous angiogenesis factors with clinical outcome (PFS)
in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
D. Scott McMeekin
Gynecologic Oncology Group
United States: Food and Drug Administration
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