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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00499733 |
Purpose
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 | Intervention |
|
Cancer |
Drug: cyclophosphamide Procedure: biopsy Procedure: cryosurgery Procedure: laboratory biomarker analysis |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Liver Cancer Lung Cancer Melanoma Salivary Gland Disorders Soft Tissue Sarcoma |
| ChemIDplus related topics: | Cyclophosphamide Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer |
| Estimated Enrollment: | 23 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of epithelial solid tumors of any of the following sites or types:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Maryland | |||||
| Brady Urological Institute at Johns Hopkins Hospital | Recruiting | ||||
| Baltimore, Maryland, United States, 21205 | |||||
| Contact: Ronald Rodriguez, MD, PhD 410-614-6662 | |||||
| Sidney Kimmel Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Ronald Rodriguez, MD, PhD | Brady Urological Institute at Johns Hopkins Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000554417, JHOC-J0685, NA_00003073 |
| First Received: | July 10, 2007 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00499733 |
| Health Authority: | Unspecified |
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