Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: recombinant interleukin-12
- Registration Number
- NCT00004893
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill breast cancer cells.
PURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer.
- Detailed Description
OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of patients who have not progressed after 6 months of therapy. II. Compare percentage of patients who have not progressed after six months with or without treatment regimen. III. Determine time to progression and overall survival in this patient population after this treatment.
OUTLINE: This is a randomized study. Patients are stratified according to disease free interval from primary diagnosis to first metastases (less than 3 years vs 3 years and longer), estrogen receptor status (positive vs negative), and disease status (complete response, partial response, detectable disease, or stable disease). Patients are randomized to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12 subcutaneously twice a week. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no progression after 1 year, may be followed as needed for new signs or symptoms and survival for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first 6 months, patients may receive interleukin-12 as in arm I. Patients without disease progression within first 6 months may also then receive interleukin-12 as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for toxicity only until interleukin-12 is discontinued.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IL12 Therapy recombinant interleukin-12 Patients begin therapy no sooner than 3 weeks and no later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12 subcutaneously twice a week. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no progression after 1 year, may be followed as needed for new signs or symptoms and survival for 5 years.
- Primary Outcome Measures
Name Time Method disease progression at 6 months
- Secondary Outcome Measures
Name Time Method time to progression Up to 1 year overall survival Up to 1 year
Trial Locations
- Locations (49)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States