Cyclophosphamide And Cryoablation In Treating Patients With Advanced Or Metastatic Epithelial Cancer

Study Overview

Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic 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.

Cancer

DRUG: cyclophosphamide
DEVICE: Cryoablation

J0685
P30CA006973 (U.S. NIH Grant/Contract)
NA_00003073 (OTHER Identifier) (OTHER: JHM IRB)
JHOC-J0685
CDR0000554417 (OTHER Identifier) (OTHER: other)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-07-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-16
First Submitted that Met QC Criteria 2007-07-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-18
First Posted (ACTUAL) 2007-07-11	Results First Posted N/A	Last Verified 2017-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

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

Participant Group/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.

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	Measure Description	Time Frame
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity		Two years

Secondary Outcome Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Ronald Rodriguez, MD, PhD, Brady Urological Institute at Johns Hopkins Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record