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Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
This study is currently recruiting participants.
Study NCT00499733   Information provided by National Cancer Institute (NCI)
First Received: July 10, 2007   Last Updated: July 3, 2009   History of Changes

July 10, 2007
July 3, 2009
June 2007
July 2010   (final data collection date for primary outcome measure)
  • Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity [ Designated as safety issue: Yes ]
  • Tumor response, according to RECIST criteria [ Designated as safety issue: No ]
  • Response, defined as the absence of a serious adverse event or unacceptable toxicity
  • Safety
Complete list of historical versions of study NCT00499733 on ClinicalTrials.gov Archive Site
 
 
 
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer

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.

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.

 
Interventional
Treatment
Cancer
  • Drug: cyclophosphamide
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
  • Procedure: cryosurgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
23
 
July 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of epithelial solid tumors of any of the following sites or types:

    • Lung (closed to accrual as of 4/2/2009)
    • Renal
    • Prostate
    • Breast (closed to accrual as of 4/2/2009)
    • Sarcoma (closed to accrual as of 4/2/2009)
    • Colon (closed to accrual as of 4/2/2009)
    • Liver(closed to accrual as of 4/2/2009)
    • Pancreatic (closed to accrual as of 4/2/2009)
    • Bone (closed to accrual as of 4/2/2009)
    • Head and neck (closed to accrual as of 4/2/2009)
    • Melanoma (closed to accrual as of 4/2/2009)
    • Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
  • Advanced or metastatic disease
  • Ineligible for or unwilling to undergo surgical resection
  • Eligible for cryotherapy but not expected to be cured by cryotherapy alone

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Creatinine < 2.5 mg/dL
  • Platelet count >75,000/mm³
  • INR< 1.5
  • No known HIV positivity
  • No active, uncontrolled infection
  • Not pregnant
  • Negative pregnancy test
  • Women of childbearing potential must practice adequate contraception
  • No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
 
United States
 
NCT00499733
 
CDR0000554417, JHOC-J0685, NA_00003073
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ronald Rodriguez, MD, PhD Brady Urological Institute at Johns Hopkins Hospital
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP