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

Cancer Clinical Trial

Official title:

Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00499733
• Other study ID #: J0685
• Secondary ID: P30CA006973NA_00
• Status: Terminated
• Phase: Early Phase 1
• Start date: June 2007
• Est. completion date: January 9, 2013

Study information

• Verified date: February 2017
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 9, 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Brady Urological Institute at Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity		Two years
Secondary	Tumor response, according to RECIST criteria	tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.	Two years