ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499733
  Purpose

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.


Condition Intervention
Cancer
Drug: cyclophosphamide
Procedure: biopsy
Procedure: cryosurgery
Procedure: laboratory biomarker analysis

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Liver Cancer    Lung Cancer    Melanoma    Salivary Gland Disorders    Soft Tissue Sarcoma   

ChemIDplus related topics:   Cyclophosphamide    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity [ Designated as safety issue: Yes ]
  • Tumor response, according to RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment:   23
Study Start Date:   June 2007
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of epithelial solid tumors of any of the following sites or types:

    • Lung
    • Renal
    • Prostate
    • Breast
    • Sarcoma
    • Colon
    • Liver
    • Pancreatic
    • Bone
    • Head and neck
    • Melanoma
    • Carcinoma of unknown primary
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499733

Locations
United States, Maryland
Brady Urological Institute at Johns Hopkins Hospital     Recruiting
      Baltimore, Maryland, United States, 21205
      Contact: Ronald Rodriguez, MD, PhD     410-614-6662        

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Ronald Rodriguez, MD, PhD     Brady Urological Institute at Johns Hopkins Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000554417, JHOC-J0685, NA_00003073
First Received:   July 10, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00499733
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
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
stage IV breast cancer
chondrosarcoma
metastatic osteosarcoma
recurrent osteosarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Bone Neoplasms
Pancreatic Neoplasms
Malignant mesenchymal tumor
Giant Cell Tumor of Bone
Osteogenic sarcoma
Giant Cell Tumors
Kaposi sarcoma
Ewing's sarcoma
Carcinoma, Adenoid Cystic
Lung Neoplasms
Metastatic squamous neck cancer with occult primary
Neuroepithelioma
Laryngeal carcinoma
Salivary Gland Diseases
Rhabdomyosarcoma
Non-small cell lung cancer
Breast Neoplasms
Carcinoma, Basal Cell
Renal cancer
Melanoma of the choroid
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Breast Neoplasms, Male
Sarcoma
Uterine sarcoma
Carcinoma, Squamous Cell
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers