Intraperitoneal chemotherapy with Paclitaxel for malignant peritoneal mesothelioma
Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study
This study is testing if weekly intraperitoneal chemotherapy with Paclitaxel can be a safe and effective treatment option for patients with malignant peritoneal mesothelioma who can't have surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT05449366 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with primary malignant peritoneal mesothelioma who are not eligible for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. Participants will receive intraperitoneal chemotherapy using Paclitaxel in weekly cycles to determine the maximum tolerable dose. The study also aims to assess the safety and feasibility of this treatment approach, as well as to investigate the pharmacokinetics of Paclitaxel in this setting. The goal is to provide a potential palliative treatment option for patients who currently have limited alternatives.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of malignant peritoneal mesothelioma who are not eligible or willing to undergo surgery.
Not a fit: Patients with extensive extra-abdominal disease or those who are not ambulatory may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new palliative option for patients with malignant peritoneal mesothelioma who cannot undergo surgery.
How similar studies have performed: While intraperitoneal chemotherapy is a recognized approach, this specific use of Paclitaxel for malignant peritoneal mesothelioma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological confirmed diagnosis of malignant peritoneal mesothelioma * Patients that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) * Age ≥ 18 years old * Written informed consent according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and national/local regulations * Patients must be ambulatory, i.e. World Health Organization-Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0 or 1 * Ability to return to the Erasmus Medical Center for adequate follow-up as required by this protocol * Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements; absolute neutrophil count \>1.5 \* 10\^9/l, platelet count \>100\*10\^9/l and Hemoglobin \>6.0mmol /l. Patients must have a Bilirubin \<1½ x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x ULN Exclusion Criteria: * Extra-abdominal disease/metastatic disease established by preoperative CT-scan of thorax-abdomen and/or PET-scan. Imaging not older than two months at time of surgery * Medical or psychological impediment to probable compliance with the protocol * Serious concomitant disease or active infections * History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis * Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study * Pregnant or lactating women; for all women of child-bearing potential a negative urine pregnancy test will be required as well as the willingness to use adequate contraception during the study until 4 weeks after finishing treatment * Absence of assurance of compliance with the protocol * An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up
Where this trial is running
Rotterdam, Zuid-Holland
- Erasmus Medical Center — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.