An Early Phase 1 interventional study of cyclophosphamide and Cryoablation in Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-01-18.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Early Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 72 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 67 (59%) have results posted.
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DISEASE CHARACTERISTICS:
Diagnosis of epithelial solid tumors of any of the following sites or types:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.
Drug: cyclophosphamide · Device: Cryoablation
500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
Also known as: cytoxan
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Time frame: Two years
Tumor response, according to RECIST criteria
tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
Time frame: Two years
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclophosphamide
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →