Head and Neck Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGValproic Acid
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.
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS * Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive * Cumulative dose of radioiodine \< 800 mCi * No radioiodine uptake on whole body scan within 18 months of enrollment * Inoperable extensive locoregional tumor mass and/or metastatic spread * Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation * Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive PATIENT CHARACTERISTICS -18 years or older Entry lab results: * Hemoglobin \> 8.0 gm/dl * Absolute Neutrophil Count \> 750 cells/mm3 * Platelet count \> 75000/mm3 * BUN \< 1.5 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * Total protein \> 6.4 * Total bilirubin should be \< 1.5 times ULN. * AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN * Amylase \< 1.5 times ULN * Albumin \> 2.5 * Ammonia \< 1.5 times ULN
Exclusion criteria
* Not pregnant * No nursing within the past 3 months * No allergy to valproic acid * No coexisting malignancy other than basal cell carcinoma * No hepatic disease or significant dysfunction * Karnofsky score \> 80 * No pancreatitis * No kidney dysfunction * Fertile patients must use effective contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Thyroglobulin Level | Baseline, 16 weeks | Number of participants with decreased thyroglobulin level after study treatment |
| Decrease in Tumor Size | Baseline, 16 weeks | Number of participants with decreased tumor size after study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increased Radioactive Iodine Uptake | Baseline, 10 weeks | Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy |
| Side Effects of Drugs Affecting Quality of Life | 17 weeks | Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment |
| Survival | up to 10 years post-study treatment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Intervention Patients receive valproic acid daily for 16 weeks. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Study Intervention |
|---|---|
| Age, Continuous | NA years |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Decrease in Thyroglobulin Level
Number of participants with decreased thyroglobulin level after study treatment
Time frame: Baseline, 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Intervention | Decrease in Thyroglobulin Level | 0 participants |
Primary
Decrease in Tumor Size
Number of participants with decreased tumor size after study treatment
Time frame: Baseline, 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Intervention | Decrease in Tumor Size | 0 participants |
Secondary
Increased Radioactive Iodine Uptake
Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
Time frame: Baseline, 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Intervention | Increased Radioactive Iodine Uptake | 3 participants |
Secondary
Side Effects of Drugs Affecting Quality of Life
Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment
Time frame: 17 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Intervention | Side Effects of Drugs Affecting Quality of Life | 0 participants |
Secondary
Survival
Time frame: up to 10 years post-study treatment
Population: Due to early termination, participants were not followed for survival after the primary outcome timeframe