NCT04213794

Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for Abdominal for Pelvic Tumors in Pediatric Patients

A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies how well heated intra-peritoneal chemotherapy with doxorubicin and cisplatin work for the treatment of abdominal or pelvic tumors that can be removed by surgery (resectable), does not respond to treatment (refractory), or has come back (recurrent). Heated intra-peritoneal chemotherapy is a procedure performed in combination with abdominal surgery for cancer that has spread to the abdomen. It involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Chemotherapy drugs, such as doxorubicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors. II. To assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy. SECONDARY OBJECTIVE: I. To assess complications and adverse events of HIPEC. II. Evaluate disease recurrence patterns: locoregional versus distant. III. Evaluate disease progression defined by radio-graphically visible nodules greater than 1.5 cm. OUTLINE: Patients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate intravenously (IV) over 12 hours. After completion of the study treatment, patients are followed every 6 months for 5 years.

Conditions

• Malignant Abdominal Neoplasm
• Malignant Pelvic Neoplasm
• Recurrent Colon Carcinoma
• Recurrent Desmoplastic Small Round Cell Tumor
• Recurrent Fallopian Tube Carcinoma
• Recurrent Gastric Carcinoma
• Recurrent Liposarcoma
• Recurrent Malignant Mesothelioma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Recurrent Rectal Carcinoma
• Recurrent Rhabdomyosarcoma
• Recurrent Sarcoma
• Refractory Colon Carcinoma
• Refractory Desmoplastic Small Round Cell Tumor
• Refractory Fallopian Tube Carcinoma
• Refractory Gastric Carcinoma
• Refractory Liposarcoma
• Refractory Malignant Mesothelioma
• Refractory Ovarian Carcinoma
• Refractory Primary Peritoneal Carcinoma
• Refractory Rectal Carcinoma
• Refractory Rhabdomyosarcoma
• Refractory Sarcoma
• Resectable Liposarcoma
• Resectable Malignant Mesothelioma
• Resectable Sarcoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Undergo HIPEC with doxorubicin and cisplatin
PROCEDURE	Cytoreductive Surgery	Undergo cytoreduction
DRUG	Doxorubicin	Undergo HIPEC with doxorubicin and cisplatin
DRUG	Hyperthermic Intraperitoneal Chemotherapy	Undergo HIPEC with doxorubicin and cisplatin
DRUG	Sodium Thiosulfate	Given IV
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2019-11-08
• Primary completion: 2024-03-04
• Completion: 2024-10-03
• First posted: 2019-12-30
• Last updated: 2025-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study