Interleukin-2 Plus Monoclonal Antibody Therapy in Treating Patients With Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Biological: interleukin 2Biological: rhuMAb
- Registration Number
- NCT00002994
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Monoclonal antibody + interleukin 2 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 Monoclonal antibody + interleukin 2 rhuMAb 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
- Primary Outcome Measures
Name Time Method Toxicity 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
- Secondary Outcome Measures
Name Time Method Lymphocyte phenotyping Days 1 & 4 of cycle 3; repeat prn in cycle 4 Anti tumor response pre registration; post tx: q 8 wks until progression or death Tumor measurement
In vitro cytotoxicity pre registration, days 1 & 4 ; of cycle 3, repeat prn at cycle 4 patient PBMC and plasma with target HER2 expressing cell lines
Trial Locations
- Locations (34)
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States