Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002921
Status:
TERMINATED
Last Update Posted:
2012-10-05
First Post:
1999-11-01
Brief Title:
S9427 Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma Phase II
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Permanently Closed Due to Lack of Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Some tumors need growth factors produced by the body to keep growing Suramin may interfere with the growth factor and stop the tumor from growing
PURPOSE Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer
PURPOSE Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer
Detailed Description:
OBJECTIVES I Assess the response of patients with adrenocortical carcinoma treated with suramin II Evaluate the qualitative and quantitative toxic effects of this therapy
OUTLINE Patients are described according to stage performance status prior radiotherapy prior surgery and prior mitotane therapy Patients receive suramin IV for 5 days in the first week then twice a week for 2 weeks and then weekly for a total of 12 weeks Hydrocortisone is taken PO twice daily Following a 12 week rest patients receive a second course those with stable or responding disease continue treatment for a maximum of four courses
PROJECTED ACCRUAL A maximum of 40 patients will be accrued at a rate of 6-7 per year
OUTLINE Patients are described according to stage performance status prior radiotherapy prior surgery and prior mitotane therapy Patients receive suramin IV for 5 days in the first week then twice a week for 2 weeks and then weekly for a total of 12 weeks Hydrocortisone is taken PO twice daily Following a 12 week rest patients receive a second course those with stable or responding disease continue treatment for a maximum of four courses
PROJECTED ACCRUAL A maximum of 40 patients will be accrued at a rate of 6-7 per year
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-9427 | OTHER | None | None |