Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07487168
Phase
PHASE1
Status
Recruiting
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Conditions

  • Peritoneal Carcinomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mitomycin C (MMC) — DRUG
    Delivered intraperitoneally as aerosol under laparoscopy.
  • Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) — DEVICE
    A drug delivery approach in which the antineoplastic agent is delivered directly into the peritoneal cavity solution under laparoscopic pressures (12 mm HG).

Study Details

This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.

Key Dates

First listed
Mar 23, 2026
Start date
Aug 5, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Mitomycin C Dose Escalation
    All participants are assigned to receive PIPAC-MMC. Dose escalation occurs via sequential cohorts using the BOIN model. No participant changes dose once assigned; each receives up to three PIPAC procedures at their assigned dose level.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Sean Dineen, MD (PRINCIPAL_INVESTIGATOR)
Trenton Avriett, PA-C (SUB_INVESTIGATOR)
Tiago Biachi de Castria, MD (SUB_INVESTIGATOR)
Kirsten Blue, PA-C (SUB_INVESTIGATOR)
Mintallah Haider, MD (SUB_INVESTIGATOR)
Iman Imanirad, MD (SUB_INVESTIGATOR)
Dae Won Kim, MD (SUB_INVESTIGATOR)
Richard Kim, MD (SUB_INVESTIGATOR)
Chandler Kracht, PA-C (SUB_INVESTIGATOR)
Abigail LaPorta (SUB_INVESTIGATOR)
Satish Maharaj, MD (SUB_INVESTIGATOR)
Kara Miller, PA-C (SUB_INVESTIGATOR)
Allan Lima Perreira, MD (SUB_INVESTIGATOR)
Christopher Ray, PA-C (SUB_INVESTIGATOR)
Tiffany Romershausen, MSN, RN, MPH (SUB_INVESTIGATOR)
Tiffany Valone, PA-C (SUB_INVESTIGATOR)
Michael Wach, MD (SUB_INVESTIGATOR)
James Nguyen, APRN (SUB_INVESTIGATOR)

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By research site
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