NCT00499733

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

Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	cyclophosphamide	500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
DEVICE	Cryoablation	Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-07-01
• Completion: 2013-01-09
• First posted: 2007-07-11
• Last updated: 2019-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study