Avelumab + Radiotherapy for Leptomeningeal Disease

Recruiting in Palo Alto (17 mi)

Overseen byPeter A Forsyth, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.

Research Team

Peter A Forsyth, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

This trial is for adults over 18 with Leptomeningeal Disease from any cancer except leukemia. They must have had no recent surgeries, treatments, or severe reactions to monoclonal antibodies and should not be on high steroid doses. Participants need proper organ function, a life expectancy over 8 weeks, and must use effective contraception.

Inclusion Criteria

It has been over 2 weeks since my last brain radiation therapy.

I am over 18 years old.

I have cancer cells in my CSF or at least 2 symptoms of LMD.

See 12 more

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have not received a live vaccine in the last 30 days.

See 22 more

Treatment Details

Interventions

Avelumab (Monoclonal Antibodies)
Whole Brain Radiotherapy (Radiation)

Trial OverviewThe study aims to determine a safe dose when combining Avelumab (an immunotherapy drug) with Whole Brain Radiotherapy in treating patients whose cancer has spread to the lining of the brain and spinal cord.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Avelumab and Whole Brain RadiotherapyExperimental Treatment2 Interventions

Avelumab 800 mg intravenously (IV) and 3000 centriGray units (cGy) Whole Brain Radiotherapy once every 2 weeks

Avelumab is already approved in Japan for the following indications: