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PI left university and study was halted prematurely. No data was analyzed.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.
PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation. |
|
| 2 | Other | If no increased uptake is seen, patients will continue on valproic acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic Acid | Drug | OUTLINE: This is a pilot study. Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment. Quality of life is assessed at the end of every week through a study diary. Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Thyroglobulin Level | Number of participants with decreased thyroglobulin level after study treatment | Baseline, 16 weeks |
| Decrease in Tumor Size | Number of participants with decreased tumor size after study treatment | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increased Radioactive Iodine Uptake | Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy | Baseline, 10 weeks |
| Side Effects of Drugs Affecting Quality of Life |
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INCLUSION CRITERIA:
DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
-18 years or older
Entry lab results:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Electron Kebebew, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Intervention | Patients receive valproic acid daily for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Intervention | Patients receive valproic acid daily for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in Thyroglobulin Level | Number of participants with decreased thyroglobulin level after study treatment | Posted | Number | participants | Baseline, 16 weeks |
|
|
17 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Intervention | Patients receive valproic acid daily for 16 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCSF PRS Administrator | University of California San Francisco | 415-502-3212 | Elaine.Cooperstein@ucsf.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment
| 17 weeks |
| Survival | up to 10 years post-study treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Increased Radioactive Iodine Uptake | Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy | Posted | Number | participants | Baseline, 10 weeks |
|
|
|
| Secondary | Side Effects of Drugs Affecting Quality of Life | Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment | Posted | Number | participants | 17 weeks |
|
|
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| Primary | Decrease in Tumor Size | Number of participants with decreased tumor size after study treatment | Posted | Number | participants | Baseline, 16 weeks |
|
|
|
| Secondary | Survival | Due to early termination, participants were not followed for survival after the primary outcome timeframe | Posted | up to 10 years post-study treatment |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
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| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |