Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042952
Status:
TERMINATED
Last Update Posted:
2013-01-17
First Post:
2002-08-05
Brief Title:
Imatinib Mesylate in Treating Patients With Progressive Refractory or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Imatinib Mesylate Gleevec Formerly Known As STI571 IND 61135 NSC 716051 In Patients With Refractory Seminoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069487 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-90105 | None | None | None |
| U10CA031946 | NIH | None | None |