Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Age >= 18 years old. 2. Histologically-confirmed primary uveal melanoma. 3. Definitive local treatment for primary tumor, including surgical resection (enucleation) or radiation therapy (radioactive plaque or external proton beam). 4. High risk for distal recurrence defined as any of the following conditions: A)
- - Confirmed both monosomy 3 and 8q amplification; B) - Class II tumor.
- - Absolute neutrophil count (ANC) ≥ 1500/mm3, platelets ≥ 100,000/mm3, and hemoglobin ≥ 8 g/dl.
- - Serum creatinine < 1.5 times upper limit of normal range (ULN) or creatinine clearance ≥ 40 ml/min.
- - Serum bilirubin < 1.5 times ULN and serum albumin > 2.0 g/dl.
- - Adequate cardiac function (EF> 50%) based on MUGA scan.
Exclusion Criteria:1. Other malignancy within 5 years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancer. 2. Metastatic uveal melanoma. 3. History of severe allergic reaction to sunitinib or valproic acid; inability to receive sunitinib or valproic acid. 4. Previous treatment with sunitinib or valproic acid for uveal melanoma. 5. Active treatment with valproic acid for non-oncological conditions, if this cannot be safely switched to an alternative agent. 6. Active epilepsy or convulsive conditions that require continuous use of anticonvulsants. 7. Patients with known urea cycle disorders (i.e.: ornithine transcarbamylase deficiency). 8. Severe cardiovascular disease within 6 months, including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebro-vascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias, uncontrollable hypertension or QT prolongation syndrome. 9. History of active liver disease (i.e. cirrhosis, viral or autoimmune hepatitis, etc.). 10. Pregnancy or unwillingness to stop breast-feeding. 11. Prior myelosuppressive chemotherapy or other investigational drug therapy within the last 6 months prior to initiation of sunitinib or valproic acid. 12. Current evidence of hematemesis, melena or gross hematuria. 13. History or presence of any significant bleeding disorders. 14. Concurrent use of a strong CYP3A4 inhibitor or inducer (refer to Section 7). These medications should be discontinued or switched to a different medication with a weaker CYP3A4 interaction prior to enrollment into the study. If patients need to continue the same medication(s), they are excluded from the study. 15. Chronic usage of aspirin greater than 81 mg/day. 16. Unable to render informed consent and to follow protocol requirements.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Sidney Kimmel Cancer Center at Thomas Jefferson University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Takami Sato, MD|
|Principal Investigator Affiliation||Thomas Jefferson University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Iris Melanoma, Stage I Intraocular Melanoma, Stage IIA Intraocular Melanoma, Stage IIB Intraocular Melanoma, Stage IIIA Intraocular Melanoma, Stage IIIB Intraocular Melanoma, Stage IIIC Intraocular Melanoma|
|Study Website:||View Trial Website|
PRIMARY OBJECTIVES: 1) To assess the efficacy of adjuvant sunitinib malate or adjuvant valproic acid used for 6 months to improve overall survival (OS) at 2 years in patients with high-risk uveal melanoma. SECONDARY OBJECTIVES: 1. To assess the efficacy of adjuvant sunitinib malate and adjuvant valproic acid used for 6 months in preventing the development of distal metastases (relapse-free survival, RFS) in patients with high-risk uveal melanoma. 2. To confirm the safety and tolerability of 6 months of adjuvant sunitinib and adjuvant valproic acid in patients with high-risk uveal melanoma. 3. To assess the quality of life during the adjuvant treatment. TERTIARY OBJECTIVES: 1) To determine whether blood myeloid-derived suppressor cells (MDSCs) concentration and other inflammatory cytokines correlates with OS and RFS. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sunitinib malate orally (PO) daily for 6 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Patients receive sunitinib malate PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Experimental: Valproic acid
Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Drug: - Sunitinib
Drug: - Valproic Acid
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.