Entinostat + Aldesleukin for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySaby George

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of entinostat when given together with aldesleukin and to see how well this works in treating patients with kidney cancer that has spread to other places in the body. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Aldesleukin may stimulate the white blood cells to kill kidney cancer cells. Giving entinostat together with aldesleukin may be a better treatment for metastatic kidney cancer.

Research Team

Saby George

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with metastatic kidney cancer who have good physical function and a life expectancy over 6 months. They can have had up to two prior treatments, but not more, and must be able to perform daily activities without significant difficulty (ECOG status 0). Participants need normal organ function tests, no recent heart issues or strokes, and non-pregnant women/men must agree to use contraception. People with certain medical conditions or those on conflicting medications cannot join.

Inclusion Criteria

I've had up to two treatments for my cancer and may have had radiation, but still have measurable cancer.

You are expected to live for at least 6 more months.

Your lactate dehydrogenase (LDH) levels are normal.

See 18 more

Exclusion Criteria

I am not allergic to entinostat or similar medications.

I am not HIV-positive or taking antiretroviral therapy.

Your heart's pumping ability is less than 45%.

See 10 more

Treatment Details

Interventions

Aldesleukin (Immunotherapy)
Entinostat (Histone Deacetylase Inhibitor)

Trial OverviewThe trial is testing the combination of entinostat (which blocks enzymes needed for tumor growth) with aldesleukin (which may activate white blood cells against cancer) in patients with advanced kidney cancer. It aims to find the best dose of entinostat that works well with aldesleukin by observing side effects and effectiveness.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (entinostat, aldesleukin)Experimental Treatment7 Interventions

Patients receive entinostat PO every 2 weeks beginning on day -14 and high-dose aldesleukin IV every 8 hours on days 1-5 and 15-19. Cycles repeat every 84 days\* in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients with evidence of tumor shrinkage may receive up to 3 cycles of high-dose aldesleukin therapy. Patients with stable disease by RECIST version 1.0 criteria, but without evidence of tumor shrinkage after two cycles will receive only entinostat until disease progression is documented.

Aldesleukin is already approved in Canada for the following indications: