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Malignant Abdominal NeoplasmEarly Phase 1TOASTITNCT04213794

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

A Early Phase 1 study testing Cisplatin, Cytoreductive Surgery and Doxorubicin in people with Malignant Abdominal Neoplasm and Malignant Pelvic Neoplasm, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 1 year to 25 years
What is being tested?
Cisplatin, Cytoreductive Surgery and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
8 Nov 2019to 3 Oct 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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 must be 1-25 years of age at the time of entry into the study
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  • 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 will be assessed for risk by radiation oncology
  • 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:
  • 1 to < 2 years 0.6mg/dL for both males and females
  • 2 to < 6 years 0.8mg/dL for both males and females
  • 6 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

Who cannot join

  • 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
  • No critical cumulative dose of previous chemotherapy (total anthracycline dose not >= 435 mg / m^2)
  • Prior HIPEC within 3 months
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Prospective Study of Heated Intra-Peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin and Cisplatin in Pediatric Patients With Pelvic and Abdominal Tumors. The TOAST IT Trial (Trial Of Adjuvant Surgical Treatment With Intraperitoneal Chemotherapy)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Cisplatin, Cytoreductive Surgery, Doxorubicin, Hyperthermic Intraperitoneal Chemotherapy, Sodium Thiosulfate
Medical subject headings
Pelvic Neoplasms, Colonic Neoplasms, Desmoplastic Small Round Cell Tumor, Fallopian Tube Neoplasms, Stomach Neoplasms, Liposarcoma, Mesothelioma, Malignant, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Undergo HIPEC with doxorubicin and cisplatin

  • Cytoreductive SurgeryProcedure or surgery

    Also called Cytoreduction

    Undergo cytoreduction

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Undergo HIPEC with doxorubicin and cisplatin

  • Hyperthermic Intraperitoneal ChemotherapyDrug

    Also called HIPEC

    Undergo HIPEC with doxorubicin and cisplatin

  • Sodium ThiosulfateDrug

    Also called Cyanide Antidote Package, Disodium Thiosulfate, S-Hydril, Sodium Hyposulfate

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, PET, PET Scan, positron emission tomography scan

    Undergo PET/CT

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

Study groups in NCT04213794
Study groupRoleWhat they receive
Treatment (cytoreduction, HIPEC)ExperimentalPatients undergo cytoreduction. Patients also undergo HIPEC over 60 minutes consisting of doxorubicin and cisplatin. Patients then receive sodium thiosulfate IV over 12 hours. Patients also undergo CT scan, MRI or PET/CT scan and blood sample collection throughout study.
Receives: Drug: Cisplatin; Procedure: Cytoreductive Surgery; Drug: Doxorubicin; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Sodium Thiosulfate; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

Secondary outcomes (9)

  1. 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.

    Measured: From the time of diagnosis of cancer up, assessed to 5 years

  2. 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.

    Measured: From the time of diagnosis of cancer up to 5 years

  3. Peritoneal-free recurrence

    Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient contact may be contacted by telephone.

    Measured: From the time of diagnosis of cancer up to 5 years

  4. 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.

    Measured: 30, 60, and, 90 days post-HIPEC procedure

  5. Incidence of mortality

    Will be tracked using NCI CTCAE version 5.

    Measured: 30 days post-HIPEC procedure

  6. Hospital length of stay

    Will be tracked using NCI CTCAE version 5.

    Measured: Up to 5 years

  7. Estimated blood loss (EBL)

    Measured: Up to 5 years

  8. Operative time

    Measured: Up to 5 years

  9. 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.

    Measured: From the time protocol treatment is initiated, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2019
  2. Study start8 Nov 2019
  3. Primary completion4 Mar 2024
  4. Study completion3 Oct 2024

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213794
Sponsor's protocol ID
MC1947
Other IDs
NCI-2019-08650, MC1947, 18-010108
Acronym
TOASTIT
Status last verified
Feb 2025
First submitted
27 Dec 2019
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cisplatin, Cytoreductive Surgery and Doxorubicin in people with Malignant Abdominal Neoplasm and Malignant Pelvic Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04213794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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