Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Recruitment status was: Recruiting
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.
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer|
- Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity [ Designated as safety issue: Yes ]
- Tumor response, according to RECIST criteria [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499733
|United States, Maryland|
|Brady Urological Institute at Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ronald Rodriguez, MD, PhD||Brady Urological Institute at Johns Hopkins Hospital|