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

NCT07487168 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Peritoneal Carcinomatosis

Interventions

DRUG

Mitomycin C (MMC)

Delivered intraperitoneally as aerosol under laparoscopy.

DEVICE

Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC)

A drug delivery approach in which the antineoplastic agent is delivered directly into the peritoneal cavity solution under laparoscopic pressures (12 mm HG).

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Sean Dineen, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07487168 on ClinicalTrials.gov