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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Abdominal Neoplasms
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Colonic Neoplasms
  • Desmoplastic Small Round Cell Tumor
  • Fallopian Tube Neoplasms
  • Liposarcoma
  • Lung Neoplasms
  • Malignant Abdominal Neoplasm
  • Malignant Pelvic Neoplasm
  • Mesothelioma
  • Mesothelioma, Malignant
  • Neoplasms
  • Ovarian Neoplasms
  • Pelvic Neoplasms
  • Rectal Neoplasms
  • Recurrence
  • 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 Desmoplastic Small Round Cell Tumor
  • Refractory Fallopian Tube Carcinoma
  • Refractory Malignant Mesothelioma
  • Refractory Ovarian Carcinoma
  • Refractory Primary Peritoneal Carcinoma
  • Refractory Rhabdomyosarcoma
  • Refractory Sarcoma
  • Resectable Liposarcoma
  • Resectable Sarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Stomach Neoplasms

NCT number NCT04213794
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Early Phase 1
Start date November 8, 2019
Completion date January 30, 2025

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