Symptoms and General Pathology

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Adenocarcinoma, Follicular

Adenocarcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Papillary Thyroid Carcinoma

Thyroid Cancer, Follicular

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Enzyme Inhibitors

Radiopharmaceuticals

Iodine

Cadexomer iodine

Patients receive iodine I 131 IM QD 5 days a week in weeks 5-6. Patients also receive pazopanib hydrochloride PO QD beginning in week 1 and continuing for 8 weeks post-radioactive iodine therapy.

pazopanib hydrochloride

iodine I 131

Laura Chow

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.

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

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

Will be predominantly descriptive with graphical information where available.

Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.03), timing, seriousness, and relatedness; and laboratory abnormalities. Descriptive statistics will be calculated for all variables and responses; continuous data will be expressed as their mean +/- standard deviation, median and range, and categorical data will be listed by frequency of occurrence and proportion of total (with 95% confidence intervals) for all enrolled patients and by dose cohort.

Assessed using RECIST criteria. Tumor response will be compared to responses and duration of TTP after last prior historical RAI treatment.

TTP will be compared to responses and duration of TTP after last prior historical RAI treatment.

GlaxoSmithKline

National Cancer Institute (NCI)

National Comprehensive Cancer Network

University of Washington

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Ad5-CMV-NIS

liothyronine sodium

reverse transcriptase-polymerase chain reaction

laboratory biomarker analysis

Brian J. Davis, M.D.

RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.

PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.

OBJECTIVES:

Primary

* To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following external beam radiotherapy.
* To determine the maximum tolerated dose of Ad5CMV-NIS in these patients.

Secondary

* To evaluate the PSA response rates, duration, and time to PSA progression in these patients.
* To evaluate the immune response to Ad5CMV-NIS.

OUTLINE: This is a dose-escalation study of Ad5CMV-NIS.

Patients receive intraprostate Ad5CMV-NIS, via transperineal injection under anesthesia, on day 1. They receive dosimetry oral iodine I 123 on day 4 and undergo image studies periodically for the next 24 hours for measurement of radioiodine uptake. Patients receive therapeutic oral iodine I 131 on day 5.

All patients with intact thyroid glands (i.e., not previously surgically removed or ablated) receive TSH suppressive doses of oral liothyronine sodium 3 times daily for 10 days prior and for 15 days post administration of iodine I 123.

Blood samples are collected periodically for measurement of PSA, fT4, and TSH; and peripheral blood cells are monitored for evidence of virus DNA via quantitative reverse-transcriptase-PCR.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 8 years. A transrectal tumor biopsy is to be performed at 3 months and 1 year post-treatment.

Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy

Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine

Mayo Clinic

Antineoplastic Agents

Azacitidine

Antimetabolites

azacitidine

Kenneth Ain, MD

RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine. This would allow the cancer to be detected and treated by radioactive iodine.

PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer.

OBJECTIVES: I. Determine the ability of azacitidine to restore iodine uptake by dedifferentiated thyroid cancer, enabling detection and treatment with iodine I 131 in patients with metastatic follicular or papillary thyroid cancer. II. Evaluate different doses and schedules of azacitidine administration to determine an optimally effective combination for restoration of iodine I 131 uptake with acceptable toxicity in this patient population. III. Determine the efficacy of azacitidine plus iodine I 131 in this patient population.

OUTLINE: This is a dose escalation study of azacitidine. Patients undergo a control phase consisting of oral liothyronine sodium twice daily on weeks 1-4 and a low iodine diet on weeks 4-7. At week 6, patients receive a scan dose of iodine I 131 followed by whole body scanning over 5 days. Beginning at week 7, patients undergo a treatment phase consisting of oral liothyronine sodium twice daily for 3 weeks, azacitidine subcutaneously daily for 10 or 20 days (weeks 7-11) and a low iodine diet on weeks 8-11. During week 11, patients undergo additional whole body scanning over 5 days followed by a therapeutic dose of iodine I 131. Patients achieving successful therapy receive 5 additional doses of azacitidine. Cohorts of 4 patients receive escalating doses of azacitidine until demonstrable radioiodine uptake is seen or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. Patients are followed weekly for 8 weeks.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.

Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer

Restoration of Radioiodine Uptake in Thyroid Carcinoma: A Clinical Trial

Lucille P. Markey Cancer Center at University of Kentucky

Hormones

Fluorodeoxyglucose F18

Decitabine

Starting dose 6 mg/m\^2 Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.

Starting dose 6 mg/m\^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.

Undergo thyrotropin-alfa stimulated radioactive iodine scan

Iodine I 131

Recombinant thyrotropin alfa

Fludeoxyglucose F 18

Positron emission tomography

Steven Sherman

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.

Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131

Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine

Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine.

Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera.

Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs \>20%, Grade 2 AEs \>10%, all Grade 3, Grade 4 and Grade 5 reported.

Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.

Decitabine: Starting dose 6 mg/m\^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.

Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan

Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan

Treatment

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Participants who received at least one dose of therapy.

Steven I. Sherman, MD / Professor

Per protocol, 1 participant interpreted by local treating investigator as responsive (increased radioiodine uptake on diagnostic scan after therapy), entered second decitabine treatment receiving radioiodine therapeutic dose. Subsequent central review of both scans for formal protocol response interpreted scans as negative for radioiodine uptake.

Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration

Grade 1, Nausea

Grade 1, Fatigue

Grade 1, Oral Mucositis

Grade 1, Pharyngolaryngeal pain

Grade 1, Decreased white blood cell

Grade 2, Fatigue

Grade 2, Decreased white blood cell

Grade 2, Neutrophil count decreased

Grade 2, Lymphocyte count decreased

Grade 3, Decreased white blood cell

Grade 3, Neutrophil count decreased

Grade 3, Febrile neutropenia

Grade 3, Infections

Grade 3, respiratory disorders

Grade 4, Decreased white blood cell

Grade 5

Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

No secondary endpoints were measured as no patient met the primary endpoint. These secondary endpoints would only have been assessed if a patient had met the primary endpoint, restoration of radioiodine uptake to justify radioiodine therapy.

Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease.

Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional). No Secondary Endpoints Were Measured as no Patient Met the Primary Endpoint.

Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease

Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level

Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level.These Secondary Endpoints Would Only Have Been Assessed if a Patient Had Met the Primary Endpoint, Restoration of Radioiodine Uptake to Justify Radioiodine Therapy.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT01413113	Recurrent Thyro... Stage IVA Folli... Stage IVA Papil... Stage IVB Folli... Stage IVB Papil... Stage IVC Folli... Stage IVC Papil...	pazopanib hydro... iodine I 131	18 Years -	University of Washington
Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy	NCT00788307	Prostate Cancer	Ad5-CMV-NIS liothyronine so... reverse transcr... laboratory biom... iodine I 131	18 Years - 120 Years	Mayo Clinic
Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer	NCT00004062	Head and Neck C...	azacitidine liothyronine so... iodine I 131	-	National Cancer Institute (NCI)
Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131	NCT00085293	Recurrent Thyro... Stage IVA Folli... Stage IVA Papil... Stage IVB Folli... Stage IVB Papil... Stage IVC Folli... Stage IVC Papil...	Decitabine Iodine I 131 Recombinant thy... Fludeoxyglucose... Positron emissi...	18 Years -	National Cancer Institute (NCI)
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	NCT01413113	Recurrent Thyro... Stage IVA Folli... Stage IVA Papil... Stage IVB Folli... Stage IVB Papil... Stage IVC Folli... Stage IVC Papil...	pazopanib hydro... iodine I 131	18 Years -	University of Washington

Spots Global Cancer Trial Database for iodine i 131

Every month we try and update this database with for iodine i 131 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.