Recurrent Thyroid Cancer Clinical Trial
Official title:
A Phase I Clinical Trial of Pazopanib in Combination With Escalating Doses of Radioactive 131I in Patients With Well-Differentiated Thyroid Carcinoma Refractory to Radioiodine, Despite Having Some Uptake
This phase I trial is studying the side effects and best dose of iodine I 131 when given together with pazopanib hydrochloride in treating patients with recurrent and/or metastatic thyroid cancer previously treated with iodine I 131 that cannot be removed by surgery. Radioactive drugs, such as iodine I 131, may carry radiation directly to cancer cells and not harm normal cells. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iodine I 131 together with pazopanib hydrochloride may be an effective treatment for thyroid cancer.
PRIMARY OBJECTIVES:
I. To determine the safety, tolerability and feasibility of administrating escalating doses
of 131I (iodine I 131) in combination with concurrent pazopanib (pazopanib hydrochloride)
therapy in order to define the maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
in patients with radioiodine (RAI)-refractory disease with minor RAI-uptake.
SECONDARY OBJECTIVES:
I. To determine the effects of pazopanib in combination with 131I on RAI-avidity, uptake and
tumor response rate (Response Evaluation Criteria In Solid Tumors [RECIST] version 1.1).
II. To determine the time to tumor progression (TTP) or recurrence (progression will be
determined by RECIST criteria and by increases in suppressed thyroglobulin levels > 50% as
compared to tumor imaging and suppressed thyroglobulin levels performed within 1 week of the
last dose of pazopanib).
OUTLINE: This is a dose-escalation study of iodine I 131.
Patients receive iodine I 131 intramuscularly (IM) once daily (QD) 5 days a week in weeks
5-6. Patients also receive pazopanib hydrochloride orally (PO) QD beginning in week 1 and
continuing for 8 weeks post-radioactive iodine therapy.
After completion of study treatment, patients are followed up at 28 days.
;
Endpoint Classification: Safety 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 |
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 | |
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 |
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 |