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Monoclonal Antibodies

Tocilizumab for Advanced Cancer (RIOT2 Trial)

Phase 1

Recruiting

Led By Patrick Wagner, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter

ECOG performance status: 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

RIOT2 Trial Summary

This trial is testing if tocilizumab is safe to infuse into MA/MPE patients in increasing doses over 4 weeks.

Who is the study for?

Adults aged 18-89 with metastatic cancer causing fluid buildup in the chest or abdomen can join this trial. They must be able to consent and handle weekly clinic visits. Excluded are those with active infections, recent immunotherapy, pregnancy, known drug allergies, autoimmune diseases, or certain abnormal blood tests.Check my eligibility

What is being tested?

The study is testing if tocilizumab can be safely given directly into the chest or abdominal cavity for patients with malignant ascites or pleural effusions. Participants will receive increasing doses once a week for four weeks through already-planned drainage catheters.See study design

What are the potential side effects?

Potential side effects of tocilizumab may include reactions at the infusion site, increased risk of infection due to immune system suppression, headaches, high blood pressure and liver function changes.

RIOT2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a procedure to drain fluid from my chest or abdomen.

Select...

I am able to care for myself and perform daily activities.

Select...

I am 18-89 years old with fluid buildup due to cancer spread.

RIOT2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Successful intra-cavitary administration of tocilizumab

Secondary outcome measures

Biomarkers

Pharmacokinetics Analysis

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

Inpatient admission

fatigue

agranulocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Tocilizumab

Placebo

RIOT2 Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment Arm - intracavitary tocilizumabExperimental Treatment1 Intervention

Four incremental weekly intra-cavitary doses of tocilizumab starting at 0.5μg/mL and increasing to 1.6μg/mL, 5μg/mL and 50μg/mL once a week over four weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor

47 Previous Clinical Trials

13,067 Total Patients Enrolled

Patrick Wagner, MDPrincipal InvestigatorDirector of Complex General Surgical Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate elderly participants aged 70 or more?

"The basic requirements for this trial stipulate that interested participants must be between 18 to 89 years old. There are two alternative studies available respectively for minors and those over 65."

Answered by AI

Are there any vacant slots for prospective participants in this experiment?

"Judging from the details published on clinicaltrials.gov, this medical trial is not in need of any further participants at present. The listing was first posted on September 1st 2023 and experienced its last update on August 30th 2023; however, there are 66 other trials that currently have open enrollment criteria."

Answered by AI

Has the FDA granted their approval for intracavitary tocilizumab as a form of therapy?

"The safety of Treatment Arm - intracavitary tocilizumab was given a score of 1 as the trial is in Phase 1, meaning there are currently limited data points illustrating its efficacy and safety."

Answered by AI

Is there an opportunity to partake in this medical research?

"The prerequisites for participation in this medical trial are a diagnosis of malignant pleural effusion and an age between 18 to 89 years old. Currently, 12 volunteers need to be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

Patrick Wagner, MD, FACS 2024. "Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016179.

All > Malignant Pleural Effusion