Study on Sunitinib Malate or Valproic Acid to Prevent Spread of High-Risk Eye Melanoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor score: 0

ClinicalTrials ID:NCT02068586

Provider View

This clinical trial is testing whether the drugs sunitinib malate or valproic acid can help prevent high-risk eye melanoma from spreading to other parts of the body. The study aims to see if these drugs can stop tumor growth by blocking signals or changing gene expression.

Patient Parameters

Program Overview

This study is exploring whether sunitinib malate or valproic acid can prevent high-risk uveal melanoma, a type of eye cancer, from spreading. Sunitinib malate may block signals that help tumor cells grow, while valproic acid might change gene expression to suppress tumor growth. The trial will assess if these treatments can improve survival rates and prevent cancer recurrence.

Description

The study has three main goals:

  1. To see if taking sunitinib malate or valproic acid for 6 months can improve survival rates in patients with high-risk uveal melanoma. (Cohort 1)
  2. To evaluate if taking sunitinib for 12 months can prevent cancer from returning in patients with high-risk uveal melanoma. (Cohort 2)
  3. To determine if combining sunitinib and valproic acid for 12 months can prevent cancer recurrence in patients with high-risk uveal melanoma. (Cohort 3)

Secondary goals include assessing the safety and effectiveness of these treatments in preventing cancer spread and improving survival. The study will also monitor blood markers to see if they correlate with patient outcomes.

Participants will be divided into three groups:

  • Cohort 1: Randomly assigned to take either sunitinib or valproic acid daily for 6 months.
  • Cohort 2: Take sunitinib daily for 12 months.
  • Cohort 3: Take both sunitinib and valproic acid daily for 12 months.

After treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years, and annually after that.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of primary uveal melanoma.
  • Completed local treatment for the primary tumor, such as surgery or radiation.
  • High risk for cancer recurrence based on specific genetic markers or tumor classification.
  • Treatment for the primary tumor must have been completed less than 6 months ago.
  • Good overall health with a performance status score of 70 or higher.
  • Women must not be pregnant and must agree to use effective birth control during and after treatment.
  • Meet specific blood count and organ function criteria.
  • Have a life expectancy of at least 5 years.

Exclusion Criteria

  • Have had another cancer within the past 5 years, except for certain skin or cervical cancers.
  • Have metastatic uveal melanoma.
  • Have severe allergies to sunitinib or valproic acid.
  • Have previously been treated with sunitinib or valproic acid for uveal melanoma.
  • Are currently taking valproic acid for non-cancer conditions and cannot switch medications.
  • Have active epilepsy or require continuous anticonvulsant medication.
  • Have certain metabolic disorders.
  • Have had severe heart disease or events in the past 6 months.
  • Have active liver disease.
  • Are pregnant or unwilling to stop breastfeeding.
  • Have had certain treatments or medications recently that could interfere with the study.
  • Have significant bleeding disorders or are taking certain medications that affect blood clotting.
  • Are unable to give informed consent or follow study requirements.
  • Have any other medical conditions that the study doctor believes would make participation inappropriate.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Cancer Center at Thomas Jefferson University19107PhiladelphiaPennsylvania

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