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 range18 Years
SexALL
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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…
What they're measuring
1
Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria