A Study of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) with Doxorubicin and Cisplatin in Pediatric Patients with Pelvic and Abdominal Rhabdomyosarcoma
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 18-010108
NCT ID: NCT04213794
Sponsor Protocol Number: MC1947
About this study
The primary purpose of this study is 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, and to assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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.
- PCI ≤ 20 and surgeons deem high likelihood of complete R0 resection.
- No evidence of distant metastases at the time of enrollment.
- 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 may be excluded based on the assessment of risk by our radiation oncology team.
- Karnofsky / Lansky Performance Score of ≥ 40 or ECOG Performance score of 3 or less.
- Laboratory studies should be performed no later than 14 days before surgery:
- Platelet count ≥ 50,000 (independent of transfusion);
- Prothrombin and Partial Thromboplastin Times ≤ 1.2 xnormal;
- Total bilirubin, SGOT, SGPT, LDH, alkaline phosphatase ≤ 2 x normal;
- Neutrophil count ≥ 750.
- Patients must have adequate renal function defined as creatinine clearance or radioisotope GFR (glomerular filtration rate) ≥ 70mL/min/1.73m^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 (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.
- 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 / m2).
- Prior HIPEC within 3 months.
- Patients with an active infection requiring treatment or having an unexplained febrile illness (Tmax > 99.5 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available