Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003914
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
1999-11-01
Brief Title:
Dolastatin 10 in Treating Patients With Advanced Kidney Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-05
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 dolastatin 10 in treating patients with advanced kidney cancer
PURPOSE Phase II trial to study the effectiveness of dolastatin 10 in treating patients with advanced kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate to dolastatin 10 in patients with advanced renal cell carcinoma II Describe the toxicities of this regimen in this patient population III Assess the development of peripheral neuropathy in this patient population using this regimen IV Assess a limited sampling of pharmacokinetics and correlate with toxicity in these patients
OUTLINE Patients receive dolastatin 10 IV every 3 weeks Treatment continues for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients with documented complete response receive an additional 2 courses and may receive retreatment at the time of progression at the discretion of the investigator Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 4-15 months
OUTLINE Patients receive dolastatin 10 IV every 3 weeks Treatment continues for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients with documented complete response receive an additional 2 courses and may receive retreatment at the time of progression at the discretion of the investigator Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 4-15 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 |
|---|---|---|---|
| P30CA015083 | NIH | None | None |
| 975002 | OTHER | None | None |
| T98-0024 | OTHER | None | None |
| 372-99 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |