Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Official Title
Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
Acronym
Not provided
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Status Module
Record Verification Date
Feb 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated per PI decision.
Expanded Access Info
No
Start Date
Jun 2007Actual
Primary Completion Date
Jul 2010Actual
Completion Date
Jan 9, 2013Actual
First Submitted Date
Jul 10, 2007
First Submission Date that Met QC Criteria
Jul 10, 2007
First Posted Date
Jul 11, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 16, 2019
Last Update Posted Date
Jan 18, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Early Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
19Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Intervention
Experimental
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
Drug: cyclophosphamide
Device: Cryoablation
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cyclophosphamide
Drug
500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Intervention
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Two years
Secondary Outcomes
Measure
Description
Time Frame
Tumor response, according to RECIST criteria
tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
Two years
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ronald Rodriguez, MD, PhD
Brady Urological Institute at Johns Hopkins Hospital
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Brady Urological Institute at Johns Hopkins Hospital