Trial · NCT00085293
Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
NCT00085293, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131. Trials, record NCT00085293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
- NCT number
- NCT00085293
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer, Stage IVC Papillary Thyroid Cancer
- Interventions
- Decitabine, Iodine I 131, Recombinant thyrotropin alfa, Fludeoxyglucose F 18, Positron emission tomography
- First posted
- 2004-06-11
- Last updated
- 2018-11-29
- Results first posted
- 2014-09-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration | Week 3 following 2 weeks of Decitabine therapy | 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. |
| Secondary | Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 6 months | 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. |
| Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease. | 6 months | 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. |
| Secondary | 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. | Baseline to 3 weeks | |
| Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease | 3 months | 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. |
| Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level | 6 months | |
| Secondary | 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. | 3 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration | Week 3 following 2 weeks of Decitabine therapy | 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. | participants | NUMBER |
| SECONDARY | Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 6 months | percentage of participants | NUMBER | |
| SECONDARY | Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease. | 6 months | 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. | ||
| SECONDARY | 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. | Baseline to 3 weeks | 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. | ||
| SECONDARY | Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease | 3 months | 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. | ||
| SECONDARY | Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level | 6 months | 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. | ||
| SECONDARY | 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. | 3 months | 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. |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration | Treatment | 0 | participants | ||
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 1, Nausea | 42 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 1, Fatigue | 33 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 1, Oral Mucositis | 25 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 1, Pharyngolaryngeal pain | 25 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 1, Decreased white blood cell | 25 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 2, Fatigue | 25 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 2, Decreased white blood cell | 25 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 2, Neutrophil count decreased | 16 | percentage of participants | |
| Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Treatment | Grade 2, Lymphocyte count decreased | 16 | percentage of participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 12 | |
| Overall Study | COMPLETED | Treatment | 12 | |
| Overall Study | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | General disorders | Treatment | 1 | 12 | 2 |
| other | Alanine aminotransferase increased | Investigations | Treatment | 1 | 12 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment | 2 | 12 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Treatment | 2 | 12 | 2 |
| other | Anorexia | Gastrointestinal disorders | Treatment | 2 | 12 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment | 1 | 12 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Treatment | 2 | 12 | 2 |
| other | Back pain | General disorders | Treatment | 1 | 12 | 1 |
| other | Chest wall pain | General disorders | Treatment | 1 | 12 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment | 2 | 12 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | ||
| Total, other adverse events | Treatment | 11 | 12 |
| Total, serious adverse events | Treatment | 9 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00085293
GET https://conductscience.org/api/trials/v1/NCT00085293/events?page=2