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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2024-10-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type PROCEDURE

Undergo blood sample collection

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin Cytoreduction Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Hydroxyldaunorubicin HIPEC Cyanide Antidote Package Disodium Thiosulfate S-Hydril Sodium Hyposulfate Sodium Thiosulfate Pentahydrate Sodium Thiosulphate Sodothiol Thiosulfate, Sodium, Pentahydrate Thiosulfuric Acid Disodium Salt CAT CAT Scan Computed Axial Tomography computerized axial tomography Computed Tomography (CT) CT Scan Magnetic Resonance Imaging Scan Magnetic Resonance / Nuclear Magnetic Resonance MR MRI MRI Scan Nuclear Magnetic Resonance Imaging NMRI Structural MRI sMRI Medical Imaging PET PET Scan positron emission tomography scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

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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 must be 1-25 years of age at the time of entry into the study
* 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

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
* No critical cumulative dose of previous chemotherapy (total anthracycline dose not \>= 435 mg / m\^2)
* 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
* 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

Minimum Eligible Age

1 Year

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No