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

Phase 1

Active, not recruiting

• 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

• Registration Number: NCT04213794
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients must have resectable, primary refractory or recurrent intra-abdominal or<br> pelvic tumors based on imaging studies with measurable disease (>= 1 cm in 2<br> perpendicular planes), or primary tumor with peritoneal implants in whom no known<br> other curative treatment exists, and/or patients not on up-front clinical trial<br><br> - Evidence of macroscopic or microscopic intra-peritoneal seeding (separate from the<br> primary tumor) identified at the time of exploratory surgery with or without primary<br> tumor resection<br><br> - Peritoneal cancer index (PCI) =< 20 and surgeons deem high likelihood of complete<br> residual tumor stage R0 (R0) resection<br><br> - No evidence of distant metastases at the time of enrollment<br><br> - Histologies to be considered include: rhabdomyosarcoma, liposarcoma, sarcoma<br> (other), ovarian cancer, fallopian tube cancer, gastric cancer, colon cancer, rectal<br> cancer, mesothelioma, and desmoplastic small-round-cell tumor<br><br> - Patients must be 1-25 years of age at the time of entry into the study<br><br> - Patients may be included in the study independent of the regimen of previous<br> surgical, radiation, or chemotherapy treatments administered. Given the increased<br> risk of entero-cutaneous fistulae observed in patients treated with HIPEC AFTER<br> radiation therapy, patients will be assessed for risk by radiation oncology<br><br> - Karnofsky / Lansky performance score of >= 40 or Eastern Cooperative Oncology Group<br> (ECOG) performance score of 3 or less<br><br> - Platelet count >= 50,000 (independent of transfusion) (performed no later than 14<br> days before surgery)<br><br> - Prothrombin and partial thromboplastin times =< 1.2 X normal (performed no later<br> than 14 days before surgery)<br><br> - Total bilirubin =< 2 X normal (performed no later than 14 days before surgery)<br><br> - Serum glutamic-oxaloacetic transaminase (SGOT) =< 2 X normal (performed no later<br> than 14 days before surgery)<br><br> - Serum glutamate pyruvate transaminase (SGPT) =< 2 X normal (performed no later than<br> 14 days before surgery)<br><br> - Lactate dehydrogenase (LDH) =< 2 X normal (performed no later than 14 days before<br> surgery)<br><br> - Alkaline phosphatase =< 2 X normal (performed no later than 14 days before surgery)<br><br> - Neutrophil count >= 750 (performed no later than 14 days before surgery)<br><br> - Patients must have adequate renal function defined as creatinine clearance<br> (performed no later than 14 days before surgery) or radioisotope GFR (glomerular<br> filtration rate) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender<br> less than the following values:<br><br> - 1 to < 2 years 0.6mg/dL for both males and females<br><br> - 2 to < 6 years 0.8mg/dL for both males and females<br><br> - 6 to <10 years 1.0mg/dL for both males and females<br><br> - A signed informed consent form (and assent form when appropriate) approved by the<br> Mayo Clinic (Institutional Review Board [IRB]) will be required for patient<br> enrollment into the study. Patients must be able to read and understand the informed<br> consent document and must sign the informed consent indicating that they are aware<br> of the investigational nature of this study<br><br>Exclusion Criteria:<br><br> - Females who are pregnant or breast-feeding during the study period will be excluded<br><br> - Distant metastatic disease not limited to peritoneum:<br><br> - Solid organ metastases (liver, central nervous system, lung)<br><br> - Known bone marrow involvement<br><br> - No critical cumulative dose of previous chemotherapy (total anthracycline dose not<br> >= 435 mg / m^2)<br><br> - Prior HIPEC within 3 months<br><br> - Patients with an active infection requiring treatment or having an unexplained<br> febrile illness (Tmax > 99.5 Fahrenheit [F]), patients with known immune deficiency<br> disorder or known human immunodeficiency virus infection<br><br> - Patients must not have any systemic illness which precludes them from being an<br> operative candidate as determined by anesthesia preoperative evaluation. This<br> includes but is not limited to, sepsis, liver failure, renal failure, cardiovascular<br> failure, pulmonary failure<br><br> - Subjects deemed unable to comply with study and/or follow-up procedures<br><br> - Subjects with a known hypersensitivity to protocol systemic chemotherapy that was<br> life-threatening, required hospitalization or prolongation of existing<br> hospitalization, or resulted in persistent or significant disability or<br> incapacitation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events of cytoreductive surgery (CRS) with heated intra-peritoneal chemotherapy (HIPEC) in this patient population

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS);Disease-free survival (DFS);Peritoneal-free recurrence;Incidence of morbidity;Incidence of mortality;Hospital length of stay;Estimated blood loss (EBL);Operative time;Progression free survival (PFS)