Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study

STATUS

Recruiting
End date

Jan 30, 2025
participants needed

43
sponsor

Mayo Clinic

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Updated on 25 May 2022

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platelet count

metastases

renal function

cancer

measurable disease

doxorubicin

prothrombin

cavity

metastasis

neutrophil count

tumor cells

blood transfusion

primary tumor

rectal cancer

gastric cancer

thromboplastin

ovarian cancer

fallopian tube

hyperthermic intraperitoneal chemotherapy

lactate dehydrogenase

peritoneal cancer

cytoreductive surgery

pelvic tumor

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.

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. Evaluate disease recurrence patterns: locoregional versus distant.

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.

Details

Condition	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
Treatment	cisplatin, doxorubicin, Sodium Thiosulfate, cytoreductive surgery, Hyperthermic Intraperitoneal Chemotherapy
Clinical Study Identifier	NCT04213794
Sponsor	Mayo Clinic
Last Modified on	25 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients must have resectable, primary refractory or recurrent intra-abdominal or pelvic tumors based on imaging studies with measurable disease (>= 1 cm in 2 perpendicular planes), or primary tumor with peritoneal implants in whom no known other curative treatment exists, and/or patients not on up-front clinical trial
	Evidence of macroscopic or microscopic intra-peritoneal seeding (separate from the primary tumor) identified at the time of exploratory surgery with or without primary tumor resection
	Peritoneal cancer index (PCI) =< 20 and surgeons deem high likelihood of complete residual tumor stage R0 (R0) resection
	No evidence of distant metastases at the time of enrollment
	Histologies to be considered include: rhabdomyosarcoma, liposarcoma, sarcoma (other), ovarian cancer, fallopian tube cancer, gastric cancer, colon cancer, rectal cancer, mesothelioma, and desmoplastic small-round-cell tumor
	Patients may be included in the study independent of the regimen of previous surgical, radiation, or chemotherapy treatments administered. Given the increased risk of entero-cutaneous fistulae observed in patients treated with HIPEC AFTER radiation therapy, patients may be excluded based on the assessment of risk by our radiation oncology team
	Karnofsky / Lansky performance score of >= 40 or Eastern Cooperative Oncology Group (ECOG) performance score of 3 or less
	Platelet count >= 50,000 (independent of transfusion) (performed no later than 14 days before surgery)
	Prothrombin and partial thromboplastin times =< 1.2 X normal (performed no later than 14 days before surgery)
	Total bilirubin =< 2 X normal (performed no later than 14 days before surgery)
	Serum glutamic-oxaloacetic transaminase (SGOT) =< 2 X normal (performed no later than 14 days before surgery)
	Serum glutamate pyruvate transaminase (SGPT) =< 2 X normal (performed no later than 14 days before surgery)
	Lactate dehydrogenase (LDH) =< 2 X normal (performed no later than 14 days before surgery)
	Alkaline phosphatase =< 2 X normal (performed no later than 14 days before surgery)
	Neutrophil count >= 750 (performed no later than 14 days before surgery)
	Patients must have adequate renal function defined as creatinine clearance (performed no later than 14 days before surgery) or radioisotope GFR (glomerular filtration rate) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender less than the following values
	to < 2 years 0.6mg/dL for both males and females
	to < 6 years 0.8mg/dL for both males and females
	to <10 years 1.0mg/dL for both males and females
	A signed informed consent form (and assent form when appropriate) approved by the Mayo
	Clinic (Institutional Review Board [IRB]) will be required for patient
	enrollment into the study. Patients must be able to read and understand the
	informed consent document and must sign the informed consent indicating that
	they are aware of the investigational nature of this study
Exclusion Criteria
	Females who are pregnant or breast-feeding during the study period will be excluded
	Distant metastatic disease not limited to peritoneum
	Solid organ metastases (liver, central nervous system, lung)
	Known bone marrow involvement
	Prior HIPEC within 3 months
	Patients with an active infection requiring treatment or having an unexplained febrile illness (Tmax > 99.5 Fahrenheit [F]), patients with known immune deficiency disorder or known human immunodeficiency virus infection
	Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, renal failure, cardiovascular failure, pulmonary failure
	Subjects deemed unable to comply with study and/or follow-up procedures
	No critical cumulative dose of previous chemotherapy (total anthracycline dose not >=
	Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacitation
	mg / m^2)

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Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study