TerminatedEarly Phase 1NCT00499733
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcyclophosphamide and Cryoablation

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 18, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Early Phase 1
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Drug: cyclophosphamide; Device: Cryoablation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Brady Urological Institute at Johns Hopkins HospitalBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2019. Always confirm current availability with the study team.

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