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
Recruitment status was Recruiting
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
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
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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:
MedlinePlus related topics:
Cancer
Liver Cancer
Lung Cancer
Lymphoma
Melanoma
Pancreatic Cancer
Prostate Cancer
Soft Tissue Sarcoma
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) |
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
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 III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage III basal cell carcinoma of the lip stage III squamous cell carcinoma of the lip and oral cavity stage III verrucous carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity |
stage IV squamous cell carcinoma of the lip and oral cavity recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity stage III inverted papilloma of the paranasal sinus and nasal cavity stage III squamous cell carcinoma of the paranasal sinus and nasal cavity |
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 May 19, 2013