Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036842
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-05-13
Brief Title:
Arsenic Trioxide in Treating Men With Germ Cell Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2004-08
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 arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the response rate confirmed complete and partial responses in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide
Determine the overall and progression-free survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Assess the biomarker response rate in patients with elevated biomarkers treated with this drug
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response
Patients are followed every 2 months for 3 years or until disease progression
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 10-40 months
Determine the response rate confirmed complete and partial responses in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide
Determine the overall and progression-free survival of patients treated with this drug
Determine the qualitative and quantitative toxic effects of this drug in these patients
Assess the biomarker response rate in patients with elevated biomarkers treated with this drug
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response
Patients are followed every 2 months for 3 years or until disease progression
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 10-40 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0207 | None | None | None |