NCT00042952

Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer

A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ovarian Dysgerminoma
• Recurrent Malignant Testicular Germ Cell Tumor
• Recurrent Ovarian Germ Cell Tumor
• Stage II Malignant Testicular Germ Cell Tumor
• Stage II Ovarian Germ Cell Tumor
• Stage III Malignant Testicular Germ Cell Tumor
• Stage III Ovarian Germ Cell Tumor
• Testicular Seminoma

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
PROCEDURE	therapeutic conventional surgery	Undergo surgical resection
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-10-01
• First posted: 2003-01-27
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States