Recurrent Thyroid Cancer Clinical Trial
Official title:
Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.
PRIMARY OBJECTIVE:
I. Determine whether decitabine can restore iodine I 131 (131I) uptake in patients with
metastatic papillary thyroid or follicular thyroid cancer lesions that are undetectable by
low-dose iodine 131I scanning.
SECONDARY OBJECTIVES:
I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by
decitabine, in these patients.
II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer
cell differentiation in these patients.
III. Determine the safety and tolerability of decitabine in patients undergoing thyroid
hormone withdrawal-induced hypothyroidism and 131I therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and
2 (course 1). On week 3, patients undergo iodine I 131 (131I) scanning using thyrotropin alfa
injections. Patients whose scan does not demonstrate iodine uptake continue suppressive
thyroid hormone therapy but receive no further study therapy. These patients undergo study
follow up.
Patients whose scan demonstrates iodine uptake undergo thyroid hormone withdrawal on weeks
4-8 and receive a second course of decitabine (as in course 1) on weeks 7 and 8. Patients
then receive 131I therapy on week 9.
Patients are followed at 3 and 6 months.
;
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 |
NCT00098813 -
Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
|
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 | |
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 |
NCT00104871 -
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
|
Phase 2 | |
Completed |
NCT00118248 -
Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
|
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 |