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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- None posted in the registry
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
Show all 54Show fewer
- 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
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
Correlative studies
| 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.
- 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)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles Shapiro, Principal investigator, Ohio State University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00006228
- Acronym / sponsor ID
- NCI-2012-01402
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2000
- Primary completion
- Jul 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trastuzumab and aldesleukin) | Experimental | Biological: trastuzumab, Biological: aldesleukin, Other: laboratory biomarker analysis, Other: pharmacological studyPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (54 listed)
- Histologically or cytologically confirmed breast cancer
- HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
- Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin)
- Unidimensionally measurable disease
- CNS metastases allowed if all of the following conditions are met:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumabGiven IV | Biological | Treatment (trastuzumab and aldesleukin) |
| aldesleukinGiven SC | Biological | Treatment (trastuzumab and aldesleukin) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (trastuzumab and aldesleukin) |
| pharmacological studyCorrelative studies | Other | Treatment (trastuzumab and aldesleukin) |
Primary outcome
Response rate using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 12 months
Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 12 months
2 secondary outcomes
Degree of NK cell expansion
Time frame: Up to 12 months
Effectiveness of patients' PBMCs in a standard ADCC assay directed against HER2 target cells
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Shapiro principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate using Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.