Head and Neck CancerPhase 2NCT00525135
Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
A Phase 2 study testing Valproic Acid in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Valproic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- No pancreatitis
- No kidney dysfunction
- Fertile patients must use effective contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Valproic Acid
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Valproic Acid |
| 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. Receives: Drug: Valproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Thyroglobulin Level
Number of participants with decreased thyroglobulin level after study treatment
Measured: Baseline, 16 weeks
Decrease in Tumor Size
Number of participants with decreased tumor size after study treatment
Measured: Baseline, 16 weeks
Secondary outcomes (3)
Increased Radioactive Iodine Uptake
Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
Measured: Baseline, 10 weeks
Side Effects of Drugs Affecting Quality of Life
Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment
Measured: 17 weeks
Survival
Measured: up to 10 years post-study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: PI left university and study was halted prematurely. No data was analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Electron Kebebew, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525135
- Sponsor's protocol ID
- Valproic Acid
- Status last verified
- Jan 2015
- First submitted
- 28 Aug 2007
- Last updated
- 3 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
- ClinicalTrials.gov ID
- NCT00525135
- Acronym / sponsor ID
- Valproic Acid
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left university and study was halted prematurely. No data was analyzed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 3 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Valproic AcidIf 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 | Drug: Valproic AcidIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic AcidOUTLINE: 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. | Drug | 1, 2 |
Primary outcome
Decrease in Thyroglobulin Level
Time frame: Baseline, 16 weeks
Number of participants with decreased thyroglobulin level after study treatment
Decrease in Tumor Size
Time frame: Baseline, 16 weeks
Number of participants with decreased tumor size after study treatment
3 secondary outcomes
Increased Radioactive Iodine Uptake
Time frame: Baseline, 10 weeks
Side Effects of Drugs Affecting Quality of Life
Time frame: 17 weeks
Survival
Time frame: up to 10 years post-study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electron Kebebew, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Thyroglobulin Level (time frame: Baseline, 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.