Clinical Trial: Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
Brief 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.
Detailed Summary:
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.
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome:
- Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
- Tumor response, according to RECIST criteria
Original Primary Outcome:
- Safety
- Response, defined as the absence of a serious adverse event or unacceptable toxicity
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: July 10, 2007
Date Started: June 2007
Date Completion:
Last Updated: February 24, 2011
Last Verified: July 2009
