Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003009
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Inhaled Interleukin-2 in Treating Patients With Metastatic or Unresectable Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Phase I Study of Inhalation of Interleukin-2 IL-2 in Patients With Metastatic or Unresectable Cancer
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Accrual
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 cancer cells Giving interleukin-2 in different ways may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer
PURPOSE Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer
Detailed Description:
OBJECTIVES I Define the safe and tolerance of an inhaled interleukin-2 IL-2 administered once or twice a day II Determine blood levels of IL-2 and whether there is detectable stimulation of immune cells in patients receiving inhalation IL-2 III Determine whether there is any shrinkage of pulmonary lesions of patients treated on this study
OUTLINE This is a two arm escalating dose study of interleukin-2 IL-2 In Arm I patients in cohorts of 3-6 are administered daily inhalations of IL-2 over 15 minutes on Monday through Friday for 4 consecutive weeks At least 3 patients are treated at each dose level and all patients in a cohort are observed for at least 2 weeks before escalating to a higher dose in absence of dose limiting toxicity Escalation stops when maximum tolerated dose MTD is determined In Arm II the initial dose is 25 percent of the MTD determined in Arm I administered by inhalation twice daily on Monday through Friday for 4 weeks Subsequent patient cohorts receive doses escalated by 33 percent above the previous dose level Responding patients continue treatment cycles of 4 weeks with 2 weeks of rest until they develop progressive disease or intolerable toxicity Stable patients may stay on treatment for a maximum of 4 cycles
PROJECTED ACCRUAL A minimum of 12-15 and a maximum of 30 patients will be accrued for this study
OUTLINE This is a two arm escalating dose study of interleukin-2 IL-2 In Arm I patients in cohorts of 3-6 are administered daily inhalations of IL-2 over 15 minutes on Monday through Friday for 4 consecutive weeks At least 3 patients are treated at each dose level and all patients in a cohort are observed for at least 2 weeks before escalating to a higher dose in absence of dose limiting toxicity Escalation stops when maximum tolerated dose MTD is determined In Arm II the initial dose is 25 percent of the MTD determined in Arm I administered by inhalation twice daily on Monday through Friday for 4 weeks Subsequent patient cohorts receive doses escalated by 33 percent above the previous dose level Responding patients continue treatment cycles of 4 weeks with 2 weeks of rest until they develop progressive disease or intolerable toxicity Stable patients may stay on treatment for a maximum of 4 cycles
PROJECTED ACCRUAL A minimum of 12-15 and a maximum of 30 patients will be accrued for this study
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-G97-1264 | None | None | None |
| LAC-USC-0I951 | None | None | None |