Breast Cancer Clinical Trial
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.
Full Description
OBJECTIVES:
Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
OUTLINE: This is a pilot study.
Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
After completion of study therapy, patients are followed periodically for up to 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of epithelial solid tumors of any of the following sites or types:
Lung (closed to accrual as of 4/2/2009)
Renal
Prostate
Breast (closed to accrual as of 4/2/2009)
Sarcoma (closed to accrual as of 4/2/2009)
Colon (closed to accrual as of 4/2/2009)
Liver(closed to accrual as of 4/2/2009)
Pancreatic (closed to accrual as of 4/2/2009)
Bone (closed to accrual as of 4/2/2009)
Head and neck (closed to accrual as of 4/2/2009)
Melanoma (closed to accrual as of 4/2/2009)
Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
Advanced or metastatic disease
Ineligible for or unwilling to undergo surgical resection
Eligible for cryotherapy but not expected to be cured by cryotherapy alone
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 3 months
Creatinine < 2.5 mg/dL
Platelet count >75,000/mm³
INR< 1.5
No known HIV positivity
No active, uncontrolled infection
Not pregnant
Negative pregnancy test
Women of childbearing potential must practice adequate contraception
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
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