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Infliximab in Treating Fatigue in Postmenopausal Women Who Have Undergone Treatment for Stage 0, Stage I, or Stage II Breast Cancer - Article


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Infliximab

Remicade



Clinical Trial: Infliximab in Treating Fatigue in Postmenopausal Women Who Have Undergone Treatment for Stage 0, Stage I, or Stage II Breast Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.

PURPOSE: This phase II trial is studying how well infliximab works in treating fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.

Condition Treatment or Intervention Phase
stage I breast cancer
stage II breast cancer
breast cancer in situ
Fatigue
 Drug: infliximab
 Procedure: anti-cytokine therapy
 Procedure: anti-tumor necrosis factor therapy
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: fatigue assessment/management
 Procedure: monoclonal antibody therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Breast Cancer;   Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Infliximab for Treatment of Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Stage 0-II Breast Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive infliximab IV over 2 hours.

Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.

After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  45 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Stage 0-II disease
  • Diagnosed ≥ 1 year ago
  • Completed treatment with surgery, radiotherapy, and/or chemotherapy for breast cancer ≥ 1 year ago
  • Cancer-related fatigue as determined by a standardized interview and a score of ≤ 50 on the energy/fatigue subscale of the SF-36
  • No evidence of metastatic or recurrent disease or new primary tumor
  • No leukemia
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS: Age

  • 45 to 65

Sex

  • Female

Menopausal status

  • Postmenopausal, as defined by 1 of the following:
  • Prior documented bilateral oophorectomy
  • No spontaneous menstrual bleeding for ≥ 12 months
  • Age 55 or older AND prior hysterectomy without oophorectomy
  • Age 54 or younger AND prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) AND follicle-stimulating hormone level in the postmenopausal range

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

Hepatic

Renal

  • No serious kidney disease
  • Creatinine ≤ 1.4 mg/dL
  • No hematuria

Cardiovascular

  • No heart failure
  • No history of cardiac events (e.g., stroke or heart attack)

Pulmonary

  • No adult asthma requiring regular steroid medication

Immunologic

Other

  • Not pregnant
  • Fasting glucose ≤ 120 mg/dL
  • Protein level normal
  • No other cancer except skin cancer
  • No demyelinating disease (e.g., multiple sclerosis or optic neuritis)
  • No insulin-dependent adult diabetes
  • No underactive or overactive thyroid that is not controlled by medication
  • No abnormal thyroid hormone
  • No neurologic disease (e.g., Parkinson''''s, Alzheimer''''s, or seizures)
  • No schizophrenia or other psychotic disorder
  • No serious peripheral neuropathy
  • Not a current smoker
  • No major depression or anxiety disorder
  • No sleep or pain disorder

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • More than 2 weeks since prior psychotropic medications (e.g., benzodiazepines or antidepressants)
  • No other concurrent immunosuppressive medications
  • No concurrent sedatives

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00112749


California
      Jonsson Comprehensive Cancer Center at UCLA, Los Angeles,  California,  90095-6900,  United States; Recruiting
Patricia A. Ganz, MD  310-206-1404    pganz@ucla.edu 

Study chairs or principal investigators

Patricia A. Ganz, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000428460; UCLA-0410033-01
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112749
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07

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November 18, 2008



Page Updated: June 1, 2005
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