Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy
OBJECTIVES: 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 chemotherapy. 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 administered. 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 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Cancer and Leukemia Group B
Chicago, Illinois, United States
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.
Time frame: Up to 2 years
Grade 1 or higher toxicities assessed using CTC)version 2
Toxicities will be tabulated.
Time frame: Up to 2 years
Duration of response
The Kaplan-Meier product-limit method will be used.
Time frame: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years
Disease-free survival
The Kaplan-Meier product-limit method will be used.
Time frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
Overall survival
The Kaplan-Meier product-limit method will be used.
Time frame: From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
Proportion of patients with mutations in the c-KIT gene
The 95% confidence interval will be estimated.
Time frame: Up to 2 years
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