Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer - Full Text View

Sponsor:	Sidney Kimmel Comprehensive Cancer Center
Collaborator:	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 Other: laboratory biomarker analysis Procedure: biopsy Procedure: cryosurgery

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

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

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

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

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000554417, JHOC-J0685, NA_00003073
Study First Received:	July 10, 2007
Last Updated:	July 3, 2009
ClinicalTrials.gov Identifier:	NCT00499733 History of Changes
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
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Neoplasms, Neuroepithelial
Alkylating Agents
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009