Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003090
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Biological Therapy in Previously Treated Patients With Non-small Cell Lung Cancer
Sponsor:
Cancer Biotherapy Research Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Bolus Interleukin-2 in Previously Treated Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2000-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 non-small cell lung cancer cells
PURPOSE Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer
PURPOSE Phase II trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the response rate and median duration of response of interleukin-2 IL-2 in patients with previously treated non-small cell lung cancer II Determine the median survival of patients treated with IL-2 III Further delineate the toxicity of IL-2 in these patients
OUTLINE This is an open label study Patients receive bolus interleukin-2 on days 1-5 and 8-12 The cycle repeats every 3 weeks Patient response is evaluated after 2 cycles Patients with stable disease partial or complete response may be treated with maintenance IL-2 for up to 4 additional cycles Patient evaluation is performed after every 2 cycles At this point patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression intolerable toxic effects or 2 cycles beyond complete response
PROJECTED ACCRUAL A maximum of 30 patients will be accrued
OUTLINE This is an open label study Patients receive bolus interleukin-2 on days 1-5 and 8-12 The cycle repeats every 3 weeks Patient response is evaluated after 2 cycles Patients with stable disease partial or complete response may be treated with maintenance IL-2 for up to 4 additional cycles Patient evaluation is performed after every 2 cycles At this point patients with stable or responding disease may be treated with IL-2 every 6 weeks until disease progression intolerable toxic effects or 2 cycles beyond complete response
PROJECTED ACCRUAL A maximum of 30 patients will be accrued
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-V97-1345 | None | None | None |
| CBRG-9602 | None | None | None |
| NBSG-9602 | None | None | None |