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Tyrosine Kinase Inhibitor

Sunitinib + Valproic Acid for Uveal Melanoma

Phase 2

Waitlist Available

Led By Takami Sato, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial compares sunitinib malate to valproic acid in preventing uveal melanoma from spreading. Sunitinib malate may stop growth signals into tumor cells and prevent them from growing. Valproic acid may change some genes in uveal melanoma and suppress tumor growth.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sunitinib side effects can include fatigue, diarrhea, skin changes, mouth sores, nausea/vomiting. Valproic acid may cause nausea/vomiting as well but also headache, dizziness, mood swings or hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (Cohort 1)

Relapse-free survival (RFS) (Cohort 2 and 3)

Secondary study objectives

Incidence of toxicity assessed according to the National Institute of Health Common Terminology Criteria for Adverse Events (NIH CTCAE) version 4.0

Overall survival (Cohort 2)

Quality of life (QOL) assessed by Functional Assessment of Cancer Therapy-General (FACT-G) questionnaires

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib

FDA approved

Valproic acid

FDA approved

Sunitinib Malate

2008

Completed Phase 3

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