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Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Intervention: trastuzumab (Biological); aldesleukin (Biological); laboratory biomarker analysis (Other); pharmacological study (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Charles Shapiro, Principal Investigator, Affiliation: Ohio State University


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. 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-HER-2 Monoclonal Antibody Trastuzumab (Herceptin) in Combination With Low Dose Interleukin-2 (Proleukin) in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Response rate using Response Evaluation Criteria in Solid Tumors (RECIST)

Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0

Secondary outcome:

Degree of NK cell expansion

Effectiveness of patients' PBMCs in a standard ADCC assay directed against HER2 target cells

Detailed description: PRIMARY OBJECTIVES: I. To estimate the response rate and toxicity to low-dose IL-2 with intermediate-"pulse" dose interleukin 2 (IL-2) and trastuzumab in patients with uni-dimensional measurable metastatic breast cancer and human epidermal growth factor receptor 2 (HER2) positive (3+ overexpression by immunohistochemistry [IHC] method or positive by fluorescent in situ hybridization [FISH]) who either have had evidence of progressive disease while receiving a trastuzumab-containing regimen, or have had progressive disease within 12 months of receiving a trastuzumab-containing regimen. SECONDARY OBJECTIVES: I. To perform correlative immunologic assays to determine the degree of natural killer (NK) cell expansion in response to low-dose IL-2, and the effectiveness of patients' peripheral blood mononuclear cells (PBMC) in a standard antibody-dependent cell-mediated cytotoxicity (ADCC) assay directed against a HER2 target cell. II. To determine the pharmacokinetics of trastuzumab using an every 2-week schedule. III. To determine Fc-gamma receptor polymorphisms from study patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab intravenously (IV) over 30-90 minutes on days 1 and 8 and aldesleukin 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 aldesleukin SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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

- Male or female

- Performance status - ECOG 0-2

- Granulocyte count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- 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)

- Creatinine no greater than 1. 5 times ULN

- LVEF at least lower limit of normal by MUGA or echocardiogram

- No congestive heart failure or active ischemic heart disease

- 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

- See Disease Characteristics

- 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

- 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


- 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

- See Disease Characteristics

- At least 4 weeks since prior major surgery

- No concurrent immunosuppressive drugs

Locations and Contacts

Ohio State University Medical Center, Columbus, Ohio 43210, United States
Additional Information

Starting date: July 2000
Last updated: October 7, 2013

Page last updated: August 23, 2015

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