Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
|ClinicalTrials.gov Identifier: NCT00499733|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 11, 2007
Last Update Posted : February 25, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: cyclophosphamide Other: laboratory biomarker analysis Procedure: biopsy Procedure: cryosurgery||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Official Title:||Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||July 2010|
- Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
- Tumor response, according to RECIST criteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499733
|United States, Maryland|
|Brady Urological Institute at Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Ronald Rodriguez, MD, PhD 410-614-6662|
|Principal Investigator:||Ronald Rodriguez, MD, PhD||Brady Urological Institute at Johns Hopkins Hospital|