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
Updated on 25 May 2022
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 IdentifierNCT04213794
SponsorMayo Clinic
Last Modified on25 May 2022

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note