Sunitinib + Valproic Acid for Uveal Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byTakami Sato, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with high-risk uveal melanoma treated within the last 6 months, not pregnant or breastfeeding, and willing to use contraception. They must have a good performance status, no other cancers in the past 5 years (with some exceptions), no history of severe allergies to trial drugs, and their organs must function well.

Inclusion Criteria

Age >= 18 years old

If female, no pregnancy

Less than 6 months from the date that local treatment (surgical or radiation) of the primary tumor was finalized

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Exclusion Criteria

You had any other type of cancer, except for certain types of skin, cervical, or early stage prostate cancer, within the past 5 years.

You have uveal melanoma that has spread to other parts of the body.

You had a serious allergic reaction to sunitinib or valproic acid before, or you can't take sunitinib or valproic acid.

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Participant Groups

The trial is testing if sunitinib malate or valproic acid can prevent high-risk eye melanoma from spreading. Participants are randomly chosen to receive either drug. Sunitinib may block tumor growth signals; valproic acid might suppress tumor growth by changing gene expression.

4Treatment groups

Experimental Treatment

Active Control

Group I: Valproic acid- (Cohort 1, Arm II)Experimental Treatment1 Intervention

Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity Quality-of-Life Assessment-Ancillary studies Laboratory Biomarker Analysis-Correlative studies

Group II: Sunitinib- (Cohort 1, Arm I)Experimental Treatment1 Intervention

Patients receive sunitinib malate PO daily for 6 months in the absence of disease progression or unacceptable toxicity Quality-of-Life Assessment-Ancillary studies - Laboratory Biomarker Analysis-Correlative studies

Group III: Sunitinib Malate (Cohort 2)Experimental Treatment1 Intervention

Patients receive sunitinib malate PO daily for 12 months in the absence of disease progression or unacceptable toxicity Quality-of-Life Assessment-Ancillary studies Laboratory Biomarker Analysis-Correlative studies

Group IV: Sunitinib Malate + Valproic Acid (Cohort 3)Active Control1 Intervention

Patients receive sunitinib malate PO daily and valproic acid PO daily for 12 months in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment-Ancillary studies Laboratory Biomarker Analysis-Correlative studies

Sunitinib Malate is already approved in European Union, United States, Australia, United Kingdom for the following indications:

🇪🇺 Approved in European Union as Sutent for: