Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Resp… (NCT00098813) | Clinical Trial Compass
CompletedPhase 2
Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
United States20 participantsStarted 2004-10
Plain-language summary
This phase II trial is studying how well romidepsin works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug
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:
* Histologically or cytologically confirmed non-medullary thyroid carcinoma, including the following cell types:
* Papillary
* Follicular
* Variants of papillary or follicular
* Hürthle cell
* Recurrent and/or metastatic disease
* Measurable disease
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
* Progressive disease during or after prior treatment, as defined by \>= 1 of the following criteria:
* Presence of new or progressive lesions on CT scan or MRI
* New lesions on bone or positron-emission tomography scan
* Rising thyroglobulin level
* Minimum of 3 consecutive rises with an interval of \>= 1 week between each determination
* Refractory to radioactive iodine (RAI)
* Absent or insufficient RAI-uptake documented by whole-body RAI scan within the past 6 months
* At least 1 lesion with absent RAI-uptake required for insufficient uptake
* No known brain metastases
* Performance status - Karnofsky 60-100%
* WBC \>= 3,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,00/mm\^3
* Bilirubin normal
* AST and ALT =\< 2.5 times upper limit of normal
* Chronic active viral hepatitis allowed provided patient is clinically stable and fulfills liver function eligibility criteria
* Creatinine normal
* Creatinine clearance \>= 60 mL/min
* QTc =\< 480 msec by ECG
* ST segment depression \< 2 mm
* LVEF \>= 50 % by echocardiogram
* No left vent…
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
Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria