Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006043
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2000-07-05
Brief Title:
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic germ cell tumors that have not responded to cisplatin
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have metastatic germ cell tumors that have not responded to cisplatin
Detailed Description:
OBJECTIVES I Determine the efficacy of temozolomide in patients with cisplatin refractory metastatic germ cell tumors II Determine the safety of this treatment in these patients
OUTLINE Patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study over 25 months
OUTLINE Patients receive oral temozolomide on days 1-5 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study over 25 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 |
|---|---|---|---|
| NCI-G00-1817 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068058 | REGISTRY | None | None |