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

Early Phase 1TerminatedNCT00499733

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

cyclophosphamideDRUG

500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.

CryoablationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Brady Urological Institute at Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity

Time frame: Two years

Secondary Outcomes

Tumor response, according to RECIST criteria

tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.

Time frame: Two years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.