Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
NCT ID: NCT00499733
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
19 participants
INTERVENTIONAL
2007-06-30
2013-01-09
Brief Summary
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PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
cyclophosphamide
500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Cryoablation
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
Interventions
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cyclophosphamide
500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Cryoablation
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Ronald Rodriguez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brady Urological Institute at Johns Hopkins Hospital
Locations
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Brady Urological Institute at Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NA_00003073
Identifier Type: OTHER
Identifier Source: secondary_id
JHOC-J0685
Identifier Type: -
Identifier Source: secondary_id
CDR0000554417
Identifier Type: OTHER
Identifier Source: secondary_id
J0685
Identifier Type: -
Identifier Source: org_study_id
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