Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003714
Status:
WITHDRAWN
Last Update Posted:
2012-02-22
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Unresectable Primary or Metastatic Kidney Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Pyrazoloacridine PZA in Previously Untreated Hepatocellular Carcinoma HCC Patients
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn
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 pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated
Detailed Description:
OBJECTIVES I Determine the response rate duration and survival in previously untreated patients with hepatocellular carcinoma treated with pyrazoloacridine PZA II Determine the nature degree and duration of toxic effects of PZA in these patients
OUTLINE Patients receive pyrazoloacridine IV over 3 hours every 3 weeks The minimum treatment period is 2 courses with tumor restaging at 6 weeks Patients with complete remission CR or partial remission PR may continue on treatment until refractory PR or for at least 3 additional courses CR Patients with stable disease continue on therapy for at least 2 more courses Patients are followed until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 24 months
OUTLINE Patients receive pyrazoloacridine IV over 3 hours every 3 weeks The minimum treatment period is 2 courses with tumor restaging at 6 weeks Patients with complete remission CR or partial remission PR may continue on treatment until refractory PR or for at least 3 additional courses CR Patients with stable disease continue on therapy for at least 2 more courses Patients are followed until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 24 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 |
|---|---|---|---|
| CDR0000066822 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchU01CA070172 |
| P30CA016672 | NIH | None | None |
| U01CA070172 | NIH | None | None |
| MDA-DM-98107 | OTHER | None | None |
| NCI-T98-0031 | None | None | None |