Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
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|ClinicalTrials.gov Identifier: NCT00499733|
Recruitment Status : Terminated (The study was terminated per PI decision.)
First Posted : July 11, 2007
Last Update Posted : January 18, 2019
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 Device: Cryoablation||Early Phase 1|
- 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)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer|
|Actual Study Start Date :||June 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||January 9, 2013|
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Other Name: cytoxan
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
- Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity [ Time Frame: Two years ]
- Tumor response, according to RECIST criteria [ Time Frame: Two years ]tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|