A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
I. Determine the activity of imatinib mesylate in patients with progressive, refractory, or
recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based
II. Determine the toxicity of this drug in this patient population. III. Determine KIT
expression and identify mutations in the c-kit gene in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity. Patients who achieve a partial response or
stable disease with normalization of human chorionic gonadotropin may undergo surgical
resection of residual lesions at each tumor status assessment. If residual viable germ cell
tumor is present in the resected specimen, patients may resume imatinib mesylate. If no
viable germ cell tumor is present in the resected specimen, then no further therapy is
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 32-38
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate defined as either a complete or partial response using RECIST criteria
Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.
Up to 2 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|