Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019123
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2001-07-11
Brief Title:
Thalidomide in Treating Patients With HIV-Associated Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE II STUDY OF ORAL THALIDOMIDE FOR PATIENTS WITH HIV INFECTION AND KAPOSIS SARCOMA
Status:
COMPLETED
Status Verified Date:
2007-11
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 Thalidomide may kill cancer cells by stopping the growth of new blood vessels to the tumor
PURPOSE Phase II trial to study the effectiveness of thalidomide in treating patients with HIV-associated Kaposis sarcoma
PURPOSE Phase II trial to study the effectiveness of thalidomide in treating patients with HIV-associated Kaposis sarcoma
Detailed Description:
OBJECTIVES I Determine the antitumor activity of thalidomide in terms of regression or stabilization of disease in patients with HIV-associated Kaposis sarcoma II Determine the toxic effects of this regimen in these patients III Determine the pharmacokinetics of this regimen in these patients
OUTLINE Patients receive oral thalidomide on day 1 Treatment continues daily for 6 months in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease after 6 months of treatment may continue treatment for an additional 6 months Patients are followed at 1 6 and 12 months
PROJECTED ACCRUAL A total of 15-25 evaluable patients will be accrued for this study within 375-625 months
OUTLINE Patients receive oral thalidomide on day 1 Treatment continues daily for 6 months in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease after 6 months of treatment may continue treatment for an additional 6 months Patients are followed at 1 6 and 12 months
PROJECTED ACCRUAL A total of 15-25 evaluable patients will be accrued for this study within 375-625 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-T95-0067N | None | None | None |
| NCI-96-C-0004E | None | None | None |