Clinical Trial Finder

Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma

Study Purpose

This randomized phase II trial studies how well sunitinib malate or valproic acid works in preventing high-risk uveal (eye) melanoma from spreading to other parts of the body. Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents these cells from growing. Valproic acid may change the expression of some genes in uveal melanoma and suppress tumor growth.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
5. Less than 6 months from the date that local treatment (surgical or radiation) of the primary tumor was finalized. 6. Karnofsky performance status (PS) scores of 70 or greater. 7. If female, no pregnancy. 8. 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 (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. 9. Adequate organ function that has been determined within 2 weeks prior to the study entry, defined as:
  • - 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.

Trial Details

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.

Trial ID:
NCT02068586

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

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.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherIndustry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
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
Additional Details

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.

Contact a Trial Team

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Philadelphia, Pennsylvania

Status

Recruiting

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Takami Sato, MD

215-955-8874

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