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Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
This study has been completed.
Study NCT00006228   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: July 9, 2009   History of Changes

September 11, 2000
July 9, 2009
January 2001
July 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00006228 on ClinicalTrials.gov Archive Site
 
 
 
Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
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

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.

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.

Phase II
Interventional
Treatment
Breast Cancer
  • Biological: aldesleukin
  • Biological: trastuzumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2009   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006228
 
CDR0000068150, OSU-99H0192, OSU-9945, NCI-195
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: Charles L. Shapiro, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP