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

Early Phase 1

Terminated

• Conditions: Cancer
• Interventions: Drug: cyclophosphamide; Device: Cryoablation

• Registration Number: NCT00499733
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Primary Completion: 2010-07
• Study Completion: 2013-01-09
• Status Verified: 2017-02
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Cryoablation	Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
Intervention	cyclophosphamide	Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.

Primary Outcome Measures

Name	Time	Method
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity	Two years

Secondary Outcome Measures

Name	Time	Method
Tumor response, according to RECIST criteria	Two years	tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.

Trial Locations

Locations (1)

Brady Urological Institute at Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States