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Home > "T" Clinical Trials Conditions > Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer  Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,Male Breast Cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.
Details: OBJECTIVES: - Determine the response rate of patients with HER2-positive metastatic breast cancer treated with trastuzumab (Herceptin) and interleukin-2 after failure on a prior trastuzumab regimen. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetics of trastuzumab in these patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1 and 8 and interleukin-2 subcutaneously (SC) on days 2-7 and 9-21. Beginning on day 22, patients receive trastuzumab IV over 30 minutes every 14 days. Patients also receive interleukin-2 SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 30 days. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Primary and/or metastatic disease - HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) - Tumors with HER2 2+ overexpression by IHC allowed if confirmed by FISH - Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin) - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone metastases - Pleural or peritoneal effusion - Ascites - Leptomeningeal disease - Lymphangitic disease - Inflammatory breast cancer - Cystic lesions - CNS lesions - CNS metastases allowed if all of the following conditions are met: - Asymptomatic - At least 3 months since prior surgery and/or cranial irradiation - At least 3 weeks since prior steroids - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN (5 times ULN for liver metastases) - Alkaline phosphatase no greater than 2 times ULN (5 times ULN for liver metastases) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - LVEF at least lower limit of normal by MUGA or echocardiogram - No congestive heart failure or active ischemic heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness, medical condition, or uncontrolled infection that would preclude study - No underlying immunodeficiency (e.g., HIV or autoimmune disease) - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - Prior cumulative doxorubicin dose no greater than 360 mg/m^2 - At least 3 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for metastatic disease - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 3 weeks since prior endocrine therapy - No concurrent corticosteroids or dexamethasone - Concurrent hormones allowed for conditions unrelated to disease (e.g., insulin for diabetes) Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy - No prior radiotherapy to study lesion, unless evidence of disease progression - No concurrent palliative radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery Other: - No concurrent immunosuppressive drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesShapiro, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, 37604
United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Additional Information:
Study ID Numbers: CDR0000068150; OSU-99H0192,OSU-9945,NCI-195
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006228
Other Recurrent Breast Cancer Studies:
1. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
2. Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
3. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
4. Biological Therapy in Treating Women With Stage IV Breast Cancer
5. Radiation Therapy After Surgery in Treating Patients With Phyllodes Tumor of the Breast
Related Studies:
Other recurrent breast cancer Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
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