Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

Therapuetic Areas:Oncology
Age Range:18 - 120
Start Date:June 2007
End Date:January 9, 2013

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Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer

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.


- 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

After completion of study therapy, patients are followed periodically for up to 3 years.


- 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


- 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


- See Disease Characteristics
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Baltimore, MD
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