Can two existing drugs keep eye cancer from spreading?
NCT ID NCT02068586
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether sunitinib or valproic acid can prevent uveal melanoma, a rare eye cancer, from spreading to other parts of the body in high-risk patients. 210 participants who have already had their primary tumor treated are randomly assigned to receive one of the drugs or a combination. The study tracks how long they live without the cancer returning or spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sunitinib and valproic acid
- What this could lead to
- If successful, this could show that taking sunitinib or valproic acid after initial treatment helps prevent uveal melanoma from spreading to other organs, potentially improving survival.
- What could go wrong
- This is a phase 2 trial, so results are still preliminary. The drugs may not work better than no treatment, and side effects like fatigue, nausea, or liver problems could occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>= 18 years old * Histologically-confirmed primary uveal melanoma * Definitive local treatment for primary tumor, including surgical resection (enucleation) or radiation therapy (radioactive plaque or external proton beam) * High risk for distal recurrence defined as any of the following conditions: A) Confirmed both monosomy 3 and 8q amplification; B) Class II tumor * Less than 6 months from the date that local treatment (surgical or radiation) of the primary tumor was finalized * Karnofsky performance status (PS) scores of 70 or greater * If female, no pregnancy * If of child-bearing potential (\< one year post-menopausal), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed (women only) or the time of initiation of sunitinib (sunitinib malate) (men only); both men and women must agree to continue using such precautions while receiving sunitinib or valproic acid and for 30 days after the final dose * Absolute neutrophil count (ANC) \>= 1500/mm\^3 * Platelets \>= 100,000/mm\^3 * 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 * Serum albumin \> 2.0 g/dl * Adequate cardiac function (ejection fraction \[EF\] \> 50%) based on multi gated acquisition (MUGA) scan or 2 dimensional-echocardiogram (2D-Echo) * Life expectancy of at least 5 years Exclusion Criteria: * 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 * Metastatic uveal melanoma * History of severe allergic reaction to sunitinib or valproic acid; inability to receive sunitinib or valproic acid * Previous treatment with sunitinib or valproic acid for uveal melanoma * Active treatment with valproic acid for non-oncological conditions, if this cannot be safely switched to an alternative agent * Active epilepsy or convulsive conditions that require continuous use of anticonvulsants * Patients with known urea cycle disorders (i.e.: ornithine transcarbamylase deficiency) * 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 * Active liver disease (i.e., cirrhosis, viral or autoimmune hepatitis, etc.) * Pregnancy or unwillingness to stop breast-feeding * Prior myelosuppressive chemotherapy or other investigational drug therapy within the last 6 months prior to initiation of sunitinib or valproic acid * Current evidence of hematemesis, melena or gross hematuria * History or presence of any significant bleeding disorders * Concurrent use of a strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor or inducer; 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 * Chronic usage of aspirin greater than 81 mg/day * Unable to render informed consent and to follow protocol requirements * Any other medical condition(s) that, at the discretion of the principal investigator (PI), would make the patient inappropriate for this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.