A Randomized Phase ll Study of Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma

Who is this study for? Patients with Melanoma
Status: Active, not recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
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• Age >= 18 years old.

• Histologically-confirmed primary uveal melanoma.

• Definitive local treatment for primary tumor, including surgical resection (enucleation) or radiation therapy (radioactive plaque or external proton beam).

• High risk for distal recurrence defined as any of the following conditions: A) - Confirmed both monosomy 3 and 8q amplification; B) - Class II tumor.

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

• Karnofsky performance status (PS) scores of 70 or greater.

• If female, no pregnancy.

• 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.

• 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

Locations
United States
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia
Time Frame
Start Date: November 19, 2014
Estimated Completion Date: June 30, 2023
Participants
Target number of participants: 150
Treatments
Experimental: Sunitinib
Patients receive sunitinib malate PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Experimental: Valproic acid
Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Sidney Kimmel Cancer Center at Thomas Jefferson University

This content was sourced from clinicaltrials.gov

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