Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003551
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Aminocamptothecin in Treating Patients With Advanced or Recurrent Kidney Cancer
Sponsor:
Emory University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of 9-Amino-20S-Camptothecin 9-AC NSC 603071 and Evaluation of Drug Resistance in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2000-07
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 aminocamptothecin in treating patients with stage III stage IV or recurrent kidney cancer
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with stage III stage IV or recurrent kidney cancer
Detailed Description:
OBJECTIVES I Determine the response rate duration of response and survival of patients with advanced renal cell carcinoma treated with aminocamptothecin colloidal dispersion II Determine the nature and degree of toxicity of aminocamptothecin in this patient population
OUTLINE Patients receive aminocamptothecin colloidal dispersion intravenously for 120 hours weekly for 2 weeks followed by 1 week of rest Courses are repeated every 3 weeks in the absence of disease progression or dose limiting toxicity Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and yearly thereafter
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
OUTLINE Patients receive aminocamptothecin colloidal dispersion intravenously for 120 hours weekly for 2 weeks followed by 1 week of rest Courses are repeated every 3 weeks in the absence of disease progression or dose limiting toxicity Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and yearly thereafter
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 2 years
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-T96-0110 | None | None | None |
| EUSM-HIC-748-96 | None | None | None |