Recurrent Thyroid Cancer Clinical Trial
Official title:
A Phase II Study of Single Agent Depsipeptide (FK228) in Radioiodine (RAI)-Refractory Metastatic Non-medullary (Papillary, Follicular, and Hurthle Cell Variants) Thyroid Carcinoma
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
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of romidepsin (depsipeptide), in terms of the proportion
of patients achieving a complete or partial response or disease stabilization, in patients
with progressive recurrent and/or metastatic non-medullary thyroid carcinoma that is
refractory to radioactive iodine (RAI).
II. Determine the safety and tolerability of this drug in these patients.
SECONDARY OBJECTIVES:
I. Document changes in RAI uptake by comparing pre- and post-treatment RAI scans in patients
treated with this drug.
II. Evaluate changes in the expression of the Na+/I- symporter (NIS) in tumors, as measured
by immunohistochemistry on pre- and post-treatment biopsy specimens; and real time reverse
transcriptase polymerase chain reaction (RT-PCR) for NIS mRNA on pre- and post-treatment
changes biopsy specimens.
III. Determine post-treatment changes in serum thyroglobulin in patients treated with this
drug.
IV. Correlate changes in post-treatment positron-emission tomography scans with whole-body
RAI scans in patients treated with this drug.
OUTLINE:
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28
days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02152137 -
Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
|
Phase 2 | |
Terminated |
NCT00095693 -
Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
|
Phase 2 | |
Completed |
NCT00470496 -
Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
|
Phase 1 | |
Active, not recruiting |
NCT01723202 -
Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer
|
Phase 2 | |
Completed |
NCT00085293 -
Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
|
Phase 2 | |
Recruiting |
NCT04892303 -
Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer
|
Phase 1 | |
Terminated |
NCT00126568 -
Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
|
Phase 2 | |
Completed |
NCT00519896 -
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
|
Phase 2 | |
Completed |
NCT01502410 -
Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer
|
Phase 2 | |
Completed |
NCT01413113 -
Iodine I 131 and Pazopanib Hydrochloride in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer Previously Treated With Iodine I 131 That Cannot Be Removed By Surgery
|
Phase 1 | |
Completed |
NCT00134043 -
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
|
Phase 2 | |
Completed |
NCT00118248 -
Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
|
Phase 2 | |
Completed |
NCT00104871 -
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
|
Phase 2 | |
Completed |
NCT00068497 -
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00004074 -
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
|
Phase 1 |