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Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
This study has been completed.

First Received on September 11, 2000.   Last Updated on February 6, 2010   History of Changes
Sponsor: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006228
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: aldesleukin
Biological: trastuzumab
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006228

Locations
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, United States, 37604
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Charles L. Shapiro, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006228     History of Changes
Other Study ID Numbers: CDR0000068150, OSU-99H0192, OSU-9945, NCI-195
Study First Received: September 11, 2000
Last Updated: February 6, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aldesleukin
Trastuzumab
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012