Malignant Pleural EffusionPhase 1RIOT2NCT06016179
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
A Phase 1 study testing Tocilizumab in people with Malignant Pleural Effusion and Malignant Ascites, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Malignant Pleural Effusion, Malignant Ascites
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ages 18-89 years
- Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.
- Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
- Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
- ECOG 0-2
- Able to read and understand consent in English and provide informed consent
Who cannot join
- Pediatric patients
- Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 2 times the upper limit of normal ALT/SGPT > 2 times the upper limit of normal Total bilirubin > 2 times the upper limit of normal Creatinine > 2.5 mg/dL Hemoglobin < 7 mg/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3
- ECOG > 3
- Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
- Pregnant and lactating women
- Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be >30 days prior to the first treatment visit
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- Investigational drug use within 30 days prior to first treatment dose
- History of systemic autoimmune disease (CRS, GCA, PJIA, RA, and SJIA)
- Patient with known hypersensitivity to tocilizumab (IL-6)
- Active infection
- Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, 15213
Patrick Wagner, MD, 412-359-3731, patrick.wagner@ahn.org
AHN Clinical Trials Contact, 412-359-3731, clinicaltrials@ahn.org
About this study
Official title: Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer
The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.
Read the detailed description
This is an open label, Phase 1, intra-patient dose escalation study to determine the feasibility of catheter-based intra-pleural and intra-peritoneal administration of tocilizumab at doses up to 50μg/mL in patients with malignant pleural effusions (MPE) and malignant ascites (MA) and to determine the frequency and type of adverse events.
This study is open to patients who have had or are having chest or abdomen drains placed during cancer treatment to relieve pressure due to buildup of cancerous fluid. Some patients have drains that are temporary (single-use), while others have drains that are left in place (indwelling) for repeated or continuous at-home drainage.
Research participants, in addition to the standard treatment above, will undergo a series of four weekly infusions of the study drug into the body cavities, using the drains to inject the drug. The dose of the drug will be increased at each of the four visits. Each treatment session will last about one hour, and participants donate 12 milliliters (1 tablespoon) of blood before and after the treatment.
Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis. Researchers will analyze the blood and fluid for markers of your immune system's reaction to the drug. The total study duration is expected to be no more than 10 weeks.
- Conditions
- Malignant Pleural Effusion, Malignant Ascites
- Being tested
- Tocilizumab
- Keywords
- Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called Actemra
Each patient will receive 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - intracavitary tocilizumab | Experimental | 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. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful intra-cavitary administration of tocilizumab
Number of patients with successful administration of tocilizumab
Measured: 6 weeks
Adverse Events
To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0
Measured: 6 weeks
Secondary outcomes (5)
Pharmacokinetics Analysis
Measuring serum receptor occupancy levels
Measured: 4 weeks
Pharmacokinetics Analysis
Measuring intracavity fluid receptor occupancy levels
Measured: 4 weeks
Biomarkers
Change in Pleural cytokine concentrations
Measured: 4 weeks
Biomarkers
Change in Peritoneal Cytokine concentrations
Measured: 4 weeks
Biomarkers
Change in immune cell density
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start30 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wagner, MD, FACS, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Patrick Wagner, MD, Principal investigator, Director of Complex General Surgical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016179
- Sponsor's protocol ID
- 2023-137
- Acronym
- RIOT2
- Status last verified
- May 2025
- First submitted
- 28 Jul 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Intra-patient Dose Escalation Study of the IL-6 Receptor Antagonist Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Pleural Effusion or Peritoneal Ascites Due to Metastatic Cancer
- ClinicalTrials.gov ID
- NCT06016179
- Acronym / sponsor ID
- RIOT2 / 2023-137
- Conditions
- Malignant Pleural Effusion, Malignant Ascites
- Keywords
- Malignant Pleural Effusion, Malignant Ascites, Tocilizumab, IL-6 receptor antagonist, peritoneal cavity, pleural cavity, intraperitoneal, intrapleural
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.
Detailed description
This is an open label, Phase 1, intra-patient dose escalation study to determine the feasibility of catheter-based intra-pleural and intra-peritoneal administration of tocilizumab at doses up to 50μg/mL in patients with malignant pleural effusions (MPE) and malignant ascites (MA) and to determine the frequency and type of adverse events.
This study is open to patients who have had or are having chest or abdomen drains placed during cancer treatment to relieve pressure due to buildup of cancerous fluid. Some patients have drains that are temporary (single-use), while others have drains that are left in place (indwelling) for repeated or continuous at-home drainage.
Research participants, in addition to the standard treatment above, will undergo a series of four weekly infusions of the study drug into the body cavities, using the drains to inject the drug. The dose of the drug will be increased at each of the four visits. Each treatment session will last about one hour, and participants donate 12 milliliters (1 tablespoon) of blood before and after the treatment.
Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis. Researchers will analyze the blood and fluid for markers of your immune system's reaction to the drug. The total study duration is expected to be no more than 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-patient dose escalation administration of tocilizumab via pleural and peritoneal catheters
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - intracavitary tocilizumab | Experimental | Drug: TocilizumabFour 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females ages 18-89 years
- Female patients must have a negative pregnancy test and agree to use contraception. Female patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 90 days after the last dose of tocilizumab. Male patients receiving tocilizumab should maintain adequate contraceptive measures during and for a minimum of 60 days after the last dose of tocilizumab.
- Biopsy-proven diagnosis of malignancy with cytologic or radiographic evidence of malignant pleural effusion or ascites
- Scheduled to undergo standard-of-care pleural or peritoneal drainage catheter placement
- ECOG 0-2
Key exclusion criteria (11 listed)
- Pediatric patients
- Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT > 2 times the upper limit of normal ALT/SGPT > 2 times the upper limit of normal Total bilirubin > 2 times the upper limit of normal Creatinine > 2.5 mg/dL Hemoglobin < 7 mg/dL White blood cell count < 3,000/ mm3 Platelet count < 70,000/mm3 Absolute neutrophil cell count < 2,000 per mm3
- ECOG > 3
- Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: ActemraEach patient will receive 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. | Drug | Treatment Arm - intracavitary tocilizumab |
Primary outcome
Successful intra-cavitary administration of tocilizumab
Time frame: 6 weeks
Number of patients with successful administration of tocilizumab
Adverse Events
Time frame: 6 weeks
To identify the frequency and type of adverse events (AE) following intrapleural or intraperitoneal administration of tocilizumab at doses up to 2.5 mg (intrapleural) or 25 mg (intraperitoneal) using CTCAE v5.0
5 secondary outcomes
Pharmacokinetics Analysis
Time frame: 4 weeks
Pharmacokinetics Analysis
Time frame: 4 weeks
Biomarkers
Time frame: 4 weeks
Biomarkers
Time frame: 4 weeks
Biomarkers
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Malignant Pleural Effusion
Not yet recruitingObservational study
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Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
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Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Wagner, MD principal investigator
Director of Complex General Surgical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tocilizumab in people with Malignant Pleural Effusion and Malignant Ascites, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Wagner, MD (412-359-3731, patrick.wagner@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful intra-cavitary administration of tocilizumab (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.