- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499733
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Brady Urological Institute at Johns Hopkins Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
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500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Other Names:
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Time Frame: Two years
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response, according to RECIST criteria
Time Frame: Two years
|
tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
|
Two years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ronald Rodriguez, MD, PhD, Brady Urological Institute at Johns Hopkins Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III basal cell carcinoma of the lip
- stage III verrucous carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent verrucous carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent adenoid cystic carcinoma of the oral cavity
- 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 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 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 squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- stage IV colon cancer
- recurrent colon cancer
- recurrent pancreatic cancer
- stage III colon cancer
- male breast cancer
- stage IIIC breast cancer
- chondrosarcoma
- recurrent melanoma
- stage IV melanoma
- ciliary body and choroid melanoma, medium/large size
- conjunctival melanoma
- stage IIIA melanoma
- stage IIIB melanoma
- stage IIIC melanoma
- stage IV pancreatic cancer
- tongue cancer
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- stage III renal cell cancer
- localized osteosarcoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- intraocular lymphoma
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- recurrent uterine sarcoma
- ovarian sarcoma
- salivary gland acinic cell tumor
- salivary gland adenoid cystic carcinoma
- salivary gland poorly differentiated carcinoma
- high-grade salivary gland mucoepidermoid carcinoma
- low-grade salivary gland mucoepidermoid carcinoma
- salivary gland malignant mixed cell type tumor
- salivary gland adenocarcinoma
- salivary gland anaplastic carcinoma
- salivary gland squamous cell carcinoma
- recurrent childhood lymphoblastic lymphoma
- stage III pancreatic cancer
- localized unresectable adult primary liver cancer
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic osteosarcoma
- recurrent osteosarcoma
- stage III adult soft tissue sarcoma
- newly diagnosed carcinoma of unknown primary
- recurrent carcinoma of unknown primary
- stage IV childhood liver cancer
- recurrent childhood liver cancer
- metastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- stage IIIA uterine sarcoma
- stage IIIB uterine sarcoma
- stage IIIC uterine sarcoma
- stage IVA uterine sarcoma
- stage IVB uterine sarcoma
- stage III childhood liver cancer
- carcinoma of unknown primary
- malignant giant cell tumor of bone
- stage IIIA intraocular melanoma
- stage IIIB intraocular melanoma
- stage IIIC intraocular melanoma
- stage IV intraocular melanoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- J0685
- P30CA006973 (U.S. NIH Grant/Contract)
- NA_00003073 (Other Identifier: JHM IRB)
- JHOC-J0685
- CDR0000554417 (Other Identifier: other)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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