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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Undergo HIPEC with doxorubicin and cisplatin
Undergo cytoreduction
Undergo HIPEC with doxorubicin and cisplatin
Undergo HIPEC with doxorubicin and cisplatin
Given IV
Undergo CT scan
Undergo MRI
Undergo PET/CT
Undergo blood sample collection
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population
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.
Time frame: Up to 6 months
Overall survival (OS)
Will be estimated using the Kaplan-Meier method. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.
Time frame: From the time of diagnosis of cancer up, assessed to 5 years
Disease-free survival (DFS)
Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.
Time frame: From the time of diagnosis of cancer up to 5 years
Peritoneal-free recurrence
Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.
Time frame: From the time of diagnosis of cancer up to 5 years
Incidence of morbidity
Will be measured using the Clavien Dindo scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: 30, 60, and, 90 days post-HIPEC procedure
Incidence of mortality
Will be tracked using NCI CTCAE version 5.
Time frame: 30 days post-HIPEC procedure
Hospital length of stay
Will be tracked using NCI CTCAE version 5.
Time frame: Up to 5 years
Estimated blood loss (EBL)
Time frame: Up to 5 years
Operative time
Time frame: Up to 5 years
Progression free survival (PFS)
The PFS is defined as the time between initiation of protocol treatment and the first occurrence of disease. It will be defined radiologically.
Time frame: From the time protocol treatment is initiated, assessed up to 5 years
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