Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: aldesleukin (Drug); trastuzumab (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute Official(s) and/or principal investigator(s):
Charles L. Shapiro, MD, Study Chair, Affiliation: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Summary
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.
Clinical Details
Official title: Phase II Trial of Anti-Her2 Monoclonal Antibody Trastuzumab (Herceptin) in Combination With Low Dose Interleukin-2 (Proleukin) in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab
Study design: Treatment
Detailed description:
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Central Illinois Hematology Oncology Center, Springfield, Illinois 62701, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois 62526, United States
Evanston Northwestern Health Care - Evanston Hospital, Evanston, Illinois 60201, United States
Ingalls Memorial Hospital, Harvey, Illinois 60426, United States
LaGrange Memorial Hospital, LaGrange, Illinois 60525, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States
Loyola University Medical Center, Maywood, Illinois 60153, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois 61602, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan 49085, United States
Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon, New Hampshire 03756-0002, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15236, United States
East Tennessee State University Cancer Center at JCMC, Johnson City, Tennessee 37604, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2001
Last updated: May 23, 2008
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