Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002994
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
1999-11-01
Brief Title:
Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-06
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 solid tumor cells Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Pilot study to examine the effectiveness of interleukin-2 plus monoclonal antibody in treating patients who have solid tumors
PURPOSE Pilot study to examine the effectiveness of interleukin-2 plus monoclonal antibody in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the toxic effects of humanized anti-HER2 monoclonal antibodies when administered in combination with interleukin-2 IL-2 in patients with solid tumors II Measure in vitro cytotoxicity using peripheral blood mononuclear cells plasma and target cell lines that express HER2 in this patient population III Phenotypically characterize effector cells at the time of antibody administration and 24 hours after three days of intermediate dose IL-2 pulsing in these patients IV Measure antitumor response in these patients
OUTLINE Cohorts of 6 patients are enrolled at 4 antibody dose levels After at least 6 patients have been treated on study for at least 30 days the next dose level may be initiated provided that fewer than 2 of the first 6 evaluable patients experience dose limiting toxicity DLT related to either the antibody or the combination of antibody with interleukin-2 IL-2 If 2 or more patients experience DLT the next cohort is enrolled at the antibody dose midway between the current and previous dose levels An additional 6 patients are entered at the maximum tolerated dose On course 1 patients receive IL-2 subcutaneously SQ daily on days 1-7 and humanized anti-HER-2 monoclonal antibodies IV over 90 minutes on day 7 Patients receive intermediate dose pulsed IL-2 SQ on days 8-10 and low dose IL-2 SQ on days 11-20 On course 2 and all subsequent courses patients receive humanized anti-HER2 monoclonal antibodies IV immediately prior to IL-2 SQ on day 1 and intermediate dose pulsed IL-2 SQ on days 1-3 Patients receive low dose IL-2 SQ on days 4-14 Treatment may be delayed up to 7 days to allow for recovery and for tumor restaging but daily low dose IL-2 is continued in this interval Patients are followed at 4 weeks and then every 8 weeks until progression or death
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE Cohorts of 6 patients are enrolled at 4 antibody dose levels After at least 6 patients have been treated on study for at least 30 days the next dose level may be initiated provided that fewer than 2 of the first 6 evaluable patients experience dose limiting toxicity DLT related to either the antibody or the combination of antibody with interleukin-2 IL-2 If 2 or more patients experience DLT the next cohort is enrolled at the antibody dose midway between the current and previous dose levels An additional 6 patients are entered at the maximum tolerated dose On course 1 patients receive IL-2 subcutaneously SQ daily on days 1-7 and humanized anti-HER-2 monoclonal antibodies IV over 90 minutes on day 7 Patients receive intermediate dose pulsed IL-2 SQ on days 8-10 and low dose IL-2 SQ on days 11-20 On course 2 and all subsequent courses patients receive humanized anti-HER2 monoclonal antibodies IV immediately prior to IL-2 SQ on day 1 and intermediate dose pulsed IL-2 SQ on days 1-3 Patients receive low dose IL-2 SQ on days 4-14 Treatment may be delayed up to 7 days to allow for recovery and for tumor restaging but daily low dose IL-2 is continued in this interval Patients are followed at 4 weeks and then every 8 weeks until progression or death
PROJECTED ACCRUAL Approximately 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 |
|---|---|---|---|
| CDR0000065541 | REGISTRY | NCI Physician Reference Desk | None |
| CLB-9661 | None | None | None |