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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00499733
First received: July 10, 2007
Last updated: February 24, 2011
Last verified: July 2009
  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
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: cryosurgery

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

Resource links provided by NLM:


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 2010 (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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00499733     History of Changes
Other Study ID Numbers: CDR0000554417, JHOC-J0685, NA_00003073
Study First Received: July 10, 2007
Last Updated: February 24, 2011
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

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 29, 2014