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

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.

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

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Patricio C. Gargollo, M.D. · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-08

Primary Completion

2024-03-04

Completion

2024-10-03

FDA Drug

Yes

Countries

• United States

Study Locations