Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045370
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-09-06
Brief Title:
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of the Safety Tolerability and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing Combining biological therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer
Determine the safety and tolerability of this regimen in these patients
Determine preliminarily any antitumor activity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive interferon alfa IFN-A subcutaneously 3 times a week Beginning on week 2 patients also receive CCI-779 IV over 30 minutes once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 20 additional patients are treated at that dose level
Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer
Determine the safety and tolerability of this regimen in these patients
Determine preliminarily any antitumor activity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive interferon alfa IFN-A subcutaneously 3 times a week Beginning on week 2 patients also receive CCI-779 IV over 30 minutes once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 20 additional patients are treated at that dose level
Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WYETH-C-C0125-32 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256468 | REGISTRY | None | None |
| NCI-G02-2104 | None | None | None |
| W-AR-3066K1-124-US | None | None | None |