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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (Cohort 1)

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

Secondary outcome measures

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

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

Valproic acid

FDA approved

Sunitinib

FDA approved

Sunitinib Malate

2008

Completed Phase 3

~3070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,943 Total Patients Enrolled

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,701 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,663 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what instances is Valproic Acid typically prescribed?

"Valproic Acid is a viable pharmacological option for treating thyroid malignancies, mental depression and metastatic pancreatic neuroendocrine tumours."

Answered by AI

Have any further experiments been conducted on the effects of Valproic Acid?

"Currently, 52 clinical trials involving Valproic Acid are in progress with 14 of those being at the Phase 3 stage. These studies are conducted across 3985 locations around the world, however many of them take place near Tampa, Florida."

Answered by AI

Has the FDA sanctioned Valproic Acid for medical use?

"Our analysis at Power gave Valproic Acid a score of 2, as there is preliminary evidence to suggest its safety but no data on the drug's efficacy has been collected yet."

Answered by AI

Is the recruitment phase of this clinical trial still open?

"This medical study is not currently enrolling individuals. The trial was initially listed on November 19th 2014, and the most recent update was August 15th 2022. On the other hand, for those looking to join a different clinical trial there are 754 active trials concerning melanoma and 52 experiments with Valproic Acid actively recruiting patients."

Answered by AI

How many individuals can potentially join this investigation?

"At present, this trial is not recruiting. Initially posted on November 19th 2014, the most recent updates to the study were made in August 15th 2022. Should you be interested in other studies related to melanoma and Valproic Acid, there are 754 trials for the former and 52 for the latter actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma

2014. "Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02068586.

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