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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00499733
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 11, 2007
Last Update Posted : February 25, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment
Cancer Drug: cyclophosphamide Other: laboratory biomarker analysis Procedure: biopsy Procedure: cryosurgery

Detailed Description:


  • 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)
Estimated Enrollment : 23 participants
Primary Purpose: Treatment
Official Title: Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
Study Start Date : June 2007
Estimated Primary Completion Date : July 2010

Primary Outcome Measures :
  1. Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
  2. Tumor response, according to RECIST criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

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 identifier (NCT number): NCT00499733

United States, Maryland
Brady Urological Institute at Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Ronald Rodriguez, MD, PhD    410-614-6662      
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ronald Rodriguez, MD, PhD Brady Urological Institute at Johns Hopkins Hospital Identifier: NCT00499733     History of Changes
Other Study ID Numbers: CDR0000554417
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
salivary gland acinic cell tumor
carcinoma of unknown primary
recurrent carcinoma of unknown primary
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
male breast cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
metastatic osteosarcoma
recurrent osteosarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists