Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery (NCT01623869) | Clinical Trial Compass
CompletedPhase 2
Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
United States16 participantsStarted 2012-07
Plain-language summary
This phase II trial studies how well trebananib works in treating patients with advanced angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Patients must have histologically confirmed angiosarcoma that is unresectable
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Patients must have had =\< 4 prior systemic treatment regimens
* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky \>= 70%
* Life expectancy of greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Hemoglobin \>= 8.5g/dL
* Platelet count \>= 60,000/mcL
* Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 times institutional ULN
* Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase\[SGPT\]) =\< 2.5 times institutional ULN
* Partial thromboplastin time (PTT) or activated (a)PTT =\< 1.5 times ULN per institutional laboratory range
* International normalized ratio(INR) =\< 1.5 (unless on warfarin)
* Creatinine =\< 1.5 times ULN OR creatinine clearance \> 40 mL/min per 24-hour urine collection or calculated according to the Cockcroft-Gault formula
* Urinary protein =\< 3…
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.