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Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer Clinical research trials and Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer. Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer  Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within 8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic or recurrent breast cancer (not confined to breast) - One prior induction chemotherapy regimen for recurrent or metastatic disease (4 weeks of treatment for 4-6 courses) resulting in stable disease, partial response, or complete response - Pleural or peritoneal effusion palliated by induction chemotherapy allowed - No uncontrolled brain metastases - Previously treated brain metastases allowed if: No evidence of progression for at least 3 months following radiotherapy and/or surgical treatment AND At least 30 days since dexamethasone or other corticosteroids AND Other metastatic site exists - No bone marrow or brain as only sites of metastases - No meningeal disease - Hormone receptor status Estrogen receptor status known --Prior/Concurrent Therapy-- - Biologic therapy: See Chemotherapy; No concurrent interleukin-11 - Chemotherapy: See Disease Characteristics; No concurrent chemotherapy; Prior chemotherapy with bone marrow progenitor support (bone marrow transplant and/or peripheral blood stem cell support) allowed in adjuvant setting only (not for metastases) - Endocrine therapy: Prior hormone therapy for breast cancer allowed; No concurrent hormones allowed except for non-cancer or cancer treatment related conditions (e.g. insulin for diabetes); No concurrent dexamethasone or other steroidal antiemetics - Radiotherapy: Prior radiotherapy allowed; No concurrent radiotherapy - Surgery: Not specified - Other: Prior bisphosphonate therapy allowed if started at least 3 months before study; No initiation of bisphosphonate therapy during study --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Menopausal status: Not specified - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed); Platelet count at least 100,000/mm3 - Hepatic: SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN); Albumin at least 3.0 g/dL; Bilirubin no greater than 1.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN; Creatinine clearance at least 60 mL/min - Other: No other active malignancy except nonmelanoma skin cancer; Not pregnant or nursing; Fertile patients must use effective contraception; No inflammatory bowel disease or active gastric ulcer; No prior autoimmune disease or immunodeficiency syndrome
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielHayes, Study Chair, Cancer and Leukemia Group B
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Additional Information:
Study ID Numbers: CDR0000067570; CLB-49806
Study Start Date: December 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004893
Other Stage 4 Breast Cancer Studies:
1. Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
2. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
3. Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
4. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
5. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
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