Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00002994|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: interleukin 2 Biological: rhuMAb||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||355 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Low-Dose Interleukin-2 Plus Recombinant Human Anti-HER2 Monoclonal Antibody in Solid Tumors|
|Study Start Date :||July 1997|
|Actual Primary Completion Date :||March 2000|
|Actual Study Completion Date :||April 2002|
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
- Toxicity [ Time Frame: Cycle 1 1st MoAb tx (Day 7), then Day 1 of ea subsequent cycle ]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 ]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 ]
- Anti tumor response [ Time Frame: pre registration; post tx: q 8 wks until progression or death ]Tumor measurement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002994
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|Study Chair:||Gini Fleming, MD||University of Chicago|