Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003778
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Dolastatin-10 in Patients With Previously Untreated RecurrentMetastatic Sarcoma
Status:
COMPLETED
Status Verified Date:
2000-09
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:
Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10
II Determine the toxicity of this regimen in this patient population
OUTLINE This is an open label multicenter study Patients are stratified according to center prior therapy histologic subtype stage of disease at diagnosis and current status of disease recurrent vs metastatic
Patients receive dolastatin 10 IV over 10 minutes Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
I Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10
II Determine the toxicity of this regimen in this patient population
OUTLINE This is an open label multicenter study Patients are stratified according to center prior therapy histologic subtype stage of disease at diagnosis and current status of disease recurrent vs metastatic
Patients receive dolastatin 10 IV over 10 minutes Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
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 |
|---|---|---|---|
| CDR0000066907 | REGISTRY | PDQ Physician Data Query | None |
| FCCC-98019 | None | None | None |
| NCI-T98-0026 | None | None | None |