Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors (NCT07487168)
Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) From Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Moffitt Cancer Center — Tampa, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Moffitt Cancer Center — Tampa, Florida
📞 Contact the Study Coordinator
Phone: (813) 745-8536
Email: valentina.diazaranzazu@moffitt.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peritoneal Carcinomatosis
- Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms — Montreal, Quebec
- Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC — Lexington, Kentucky
- A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery — Tampa, Florida
- Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC) — Montreal, Quebec
- Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis — Orange, California
Explore by condition: All Peritoneal Carcinomatosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.