NCT00006228

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

September 11, 2000

Last Update Submit

October 7, 2013

Conditions

HER2-positive Breast CancerMale Breast CancerRecurrent Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

    Up to 12 months

  • Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0

    Up to 12 months

Secondary Outcomes (2)

  • Degree of NK cell expansion

    Up to 12 months

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

    Up to 12 months

Study Arms (1)

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.

Biological: trastuzumabBiological: aldesleukinOther: laboratory biomarker analysisOther: pharmacological study

Interventions

trastuzumabBIOLOGICAL

Given IV

Treatment (trastuzumab and aldesleukin)
aldesleukinBIOLOGICAL

Given SC

Treatment (trastuzumab and aldesleukin)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (trastuzumab and aldesleukin)
pharmacological studyOTHER

Correlative studies

Treatment (trastuzumab and aldesleukin)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

Trastuzumabaldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Charles Shapiro

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Primary Completion

July 1, 2003

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)