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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.
ClinicalTrials.gov Identifier: NCT00499733
Recruitment Status : Terminated (The study was terminated per PI decision.)
First Posted : July 11, 2007
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cancer Drug: cyclophosphamide Device: Cryoablation Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
Actual Study Start Date : June 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 9, 2013


Arm Intervention/treatment
Experimental: Intervention
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
Drug: cyclophosphamide
500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Other Name: cytoxan

Device: Cryoablation
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.




Primary Outcome Measures :
  1. Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Tumor response, according to RECIST criteria [ Time Frame: Two years ]
    tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00499733


Locations
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United States, Maryland
Brady Urological Institute at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ronald Rodriguez, MD, PhD Brady Urological Institute at Johns Hopkins Hospital

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00499733     History of Changes
Other Study ID Numbers: J0685
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00003073 ( Other Identifier: JHM IRB )
JHOC-J0685
CDR0000554417 ( Other Identifier: other )
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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
chondrosarcoma
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
recurrent childhood soft tissue sarcoma

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