HER2-positive Breast CancerPhase 2NCT00006228

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

A Phase 2 study testing trastuzumab, aldesleukin and laboratory biomarker analysis in people with HER2-positive Breast Cancer and Male Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer
What is being tested?: trastuzumab, aldesleukin and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: Jul 2000to Jul 2003
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

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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 diabetes)
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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Being tested: trastuzumab, aldesleukin, laboratory biomarker analysis, pharmacological study
Medical subject headings: Breast Neoplasms, Male, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

trastuzumabBiological
Given IV
aldesleukinBiological
Given SC
laboratory biomarker analysisOther
Correlative studies
pharmacological studyOther
Correlative studies

Study groups in NCT00006228
Study group	Role	What they receive
Treatment (trastuzumab and aldesleukin)	Experimental	Patients receive trastuzumab IV over 30-90 minutes on days 1 and 8 and aldesleukin 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. Receives: Biological: trastuzumab; Biological: aldesleukin; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

Response rate using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Up to 12 months
Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0
Measured: Up to 12 months

Secondary outcomes (2)

Degree of NK cell expansion
Measured: Up to 12 months
Effectiveness of patients' PBMCs in a standard ADCC assay directed against HER2 target cells
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2000Jul 2003

First posted27 Jan 2003 (estimated)
Study startJul 2000
Primary completionJul 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00006228
Sponsor's protocol ID: NCI-2012-01402
Other IDs: NCI-2012-01402, CDR0000068150, OSU-99H0192, OSU-9945, NCI-195, 9945, 195, N01CM17102
Status last verified: Oct 2013
First submitted: 11 Sep 2000
Last updated: 8 Oct 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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