Vorinostat for Uveal Melanoma

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: HDAC inhibitors, Warfarin

Disqualifiers: Brain metastases, Second malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks per course, repeating

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well vorinostat works in treating patients with melanoma of the eye that has spread to other parts of the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Alexander N Shoushtari

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with metastatic uveal melanoma (eye melanoma that has spread) can join this trial. They must have measurable disease, acceptable organ function tests, and a life expectancy over 3 months. Participants need to agree to use contraception and cannot be pregnant or breastfeeding. Those with certain serious health conditions or taking specific medications are excluded.

Inclusion Criteria

You have a low level of white blood cells.

You need to have a certain number of a type of white blood cell called neutrophils in your blood.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Patients who are receiving any other investigational agents

No concomitant anti-cancer chemotherapy or other systemic drugs. Palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria

You have tried other treatments before. You need to wait at least 3 weeks after your last treatment, and 6 weeks if the last treatment included specific drugs. Your doctor thinks your disease got worse after the last treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vorinostat orally twice daily for 3 days weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

4 weeks per course, repeating

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 12 weeks

Treatment Details

Interventions

• Vorinostat

Trial Overview The trial is testing Vorinostat's effectiveness in treating metastatic uveal melanoma by inhibiting enzymes needed for tumor cell growth. It includes laboratory biomarker analysis to monitor the response and requires prior progression on other therapies.

Participant Groups

Group I: Treatment (vorinostat) Experimental Treatment 2 Interventions

Patients receive vorinostat PO BID for 3 days weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Vorinostat is already approved in United States, European Union for the following indications:

Approved in United States as Zolinza for:

• Cutaneous T-cell lymphoma

Approved in European Union as Zolinza for:

• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Institut Curie Paris

Collaborator

Trials

1

Recruited

40+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Moffitt Cancer Center P2C

Collaborator

Trials

1

Recruited

40+