Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer (NCT00499733) | Clinical Trial Compass
TerminatedEarly Phase 1
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Stopped: The study was terminated per PI decision.
United States19 participantsStarted 2007-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Timeframe: Two years
Trial details
NCT IDNCT00499733
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins