Status:
COMPLETED
A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Thyroid Neoplasm
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
Background: * Patients who have advanced thyroid cancer have a low long-term survival rate. These types of thyroid cancer do not respond well to conventional surgery or radiation, or to specific thyr...
Detailed Description
Background: Patients who have advanced differentiated thyroid cancers (Stage IV) have a five-year survival of only 25%. Clinically this results in more aggressive growth, metastasis, decreased or los...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (less than 1%) on radioiodine scan or are unresponsive to radioiodine therapy. Unresponsiveness to radioiodine therapy is defined as a patient s thyroglobulin not falling to less than 2ng/ml within 6 months after previous radioiodine ablative treatment.
- Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable.
- Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies. Patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging. (The presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease. However, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive.).
- Within 18 months of enrollment, patients must have had an radioactive iodine (RAI) scan, showing no or therapeutically insignificant RAI uptake (less than or equal to 1%).
- Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy.
- Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions.
- Greater than or equal to 18 years of age.
- Must be able to understand and sign the Informed Consent Document.
- Clinical performance status of Eastern Oncology Cooperative Group (ECOG) less than or equal to 1.
- Life expectancy of greater than three months.
- Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) within 72 hours prior to study entry and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued. All males of child fathering potential must also be willing to practice effective birth control.
- Laboratory results must be within the following parameters before entry:
- Absolute Neutrophil Count greater than 750 cells/mm(3)
- Hemoglobin greater than 8.0 gm/dl
- Platelet count greater than 75000/mm(3)
- Creatinine less tha 1.5 times upper limit of normal (ULN)
- Total protein greater than 6.4.
- Total bilirubin should be less than 1.5 times ULN.
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than 1.5 times ULN.
- Amylase less than 1.5 times ULN
- Ammonia less than 1.5 times ULN
- EXCLUSION CRITERIA:
- Allergy to valproic acid.
- Current coexisting malignancy other than basal cell carcinoma.
- Women of child-bearing potential who are pregnant or breastfeeding.
- Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately.
- Active systemic infections, coagulation disorders or other major medical illnesses.
- Patients taking tolbutamide, warfarin, zidovudine, benzodiazepines, clonazepam, diazepam.
- Seizure disorder.
Exclusion
Key Trial Info
Start Date :
September 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01182285
Start Date
September 24 2010
End Date
April 28 2016
Last Update
May 16 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892