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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT06016179
Phase
PHASE1
Status
Recruiting
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Conditions

  • Malignant Ascites
  • Malignant Pleural Effusion

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    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 Details

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.

Key Dates

Start date
Jan 30, 2024
Status verified
May 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm - intracavitary tocilizumab
    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.

Primary Outcome Measure

Successful intra-cavitary administration of tocilizumab [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Allegheny Health Network Cancer InstitutePittsburghPennsylvania15213
Patrick Wagner, MD
[email protected]
412-359-3731
AHN Clinical Trials Contact
[email protected]
412-359-3731
Patrick Wagner, MD (PRINCIPAL_INVESTIGATOR)
Catherine Lewis, MD, PhD (SUB_INVESTIGATOR)
Stephanie Baltaji, MD (SUB_INVESTIGATOR)
David Bartlett, MD (SUB_INVESTIGATOR)
Alexander Shannon, MD (SUB_INVESTIGATOR)

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By research site
Allegheny Health Network Cancer Institute· Pittsburgh, PA

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