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.
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
OBJECTIVES:
- Determine the association between the body''''s immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
- Determine whether treatment with infliximab affects energy and immune function in these patients.
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
- No anemia
- No blood disease (e.g., hemophilia or aplastic anemia)
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
- No HIV positivity
- No other immune deficiency (e.g., selective immunoglobulin A deficiency)
- No autoimmune disease (e.g., lupus, rheumatoid arthritis, or chronic fatigue syndrome)
- No inflammatory disease (e.g., ulcerative colitis or Crohn''''s disease)
- No other chronic and/or current infectious disease (e.g., tuberculosis)
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
California
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, 90095-6900, United States; Recruiting
Patricia A. Ganz, MD, Principal Investigator, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
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
Resources
- Infliximab (Drug Digest)
- Remicade (Drug Digest)

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