Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
RATIONALE: Interleukin-2 may stimulate a person's 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.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: interleukin 2
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors|
- Toxicity [ Time Frame: Cycle 1 1st MoAb tx (Day 7), then Day 1 of ea subsequent cycle ] [ Designated as safety issue: Yes ]toxicity of anti-Her2 MoAB given in combo w/ IL-2
- In vitro cytotoxicity [ Time Frame: pre registration, days 1 & 4 ; of cycle 3, repeat prn at cycle 4 ] [ Designated as safety issue: No ]patient PBMC and plasma with target HER2 expressing cell lines
- Lymphocyte phenotyping [ Time Frame: Days 1 & 4 of cycle 3; repeat prn in cycle 4 ] [ Designated as safety issue: No ]
- Anti tumor response [ Time Frame: pre registration; post tx: q 8 wks until progession or death ] [ Designated as safety issue: No ]Tumor measurement
|Study Start Date:||July 1997|
|Study Completion Date:||April 2002|
|Primary Completion Date:||March 2000 (Final data collection date for primary outcome measure)|
Experimental: Monoclonal antibody + interleukin 2
Cycle 1: low dose IL2 days 1-7; MoAb day 7; intermediate dose IL-2 days 8-10; Low dose IL2 days 11-20.
Cycle 2 & all subsequent cycles: MoAb day 1; intermediate dose IL2 days 1-3; low dose IL2 days 4-14
Biological: interleukin 2
low dose: 1 million IU/square meter subq injection q day days 1-7 and 11-20 cycle 1; days 4-14 subsequent cycles Intermediate dose: 12 million IU/square meter subq injection on days 8-10 of cycle 1; days 1-3 of subsequent cyclesBiological: rhuMAb
90 min IV infusion day 7 of each cycle
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002994
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|Study Chair:||Gini F. Fleming, MD||University of Chicago|