Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016237
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2001-05-06
Brief Title:
Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney Bladder or Lung Cancer That Has Not Responded to Previous Treatment
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Phase I Dose-Escalation Study of the Pharmacokinetic Safety Tolerability and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer
Status:
COMPLETED
Status Verified Date:
2002-06
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 Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney bladder or lung cancer
PURPOSE Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney bladder or lung cancer that has not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney bladder or lung cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma II Characterize the pharmacokinetics of this drug in these patients III Assess the overall toxicity and safety of this drug in these patients IV Determine the rate of objective response in patients treated with this drug
OUTLINE This is a dose-escalation multicenter study Patients receive KSA-interleukin-2 KSA-IL-2 IV over 1 hour on days 1-5 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 33 of the patients experience a dose-limiting toxicity Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for this study within 6-12 months
OUTLINE This is a dose-escalation multicenter study Patients receive KSA-interleukin-2 KSA-IL-2 IV over 1 hour on days 1-5 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 33 of the patients experience a dose-limiting toxicity Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for this study within 6-12 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 |
|---|---|---|---|
| NCI-G01-1944 | None | None | None |
| MSKCC-00141 | None | None | None |
| EMD-EMR-62-206-003 | None | None | None |