Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer
Peritoneal Neoplasms, Retroperitoneal Neoplasms, Gastrointestinal Neoplasms
About this trial
This is an interventional treatment trial for Peritoneal Neoplasms focused on measuring Children, Pediatric, Peritoneal Tumor, Retroperitoneal Tumor, Gastrointestinal Adenocarcinoma, Desmoplastic Round Cell Tumor, Neuroblastoma, Ovarian Germ Cell, Sarcoma, Adrenocorticocarcinoma, Wilms' Tumor, Rhabdomyosarcoma, Desmoplastic Small Round Cell Tumor, Recurrent Tumors, Cisplatin, Platinol®-AQ, Platinol®, CDDP, Abdominal Wash, Hyperthermic Perfusion, Continuous Hyperthermic Peritoneal Perfusion, CHPP
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 3 and less than or equal to 18 years
- Histologically proven diffuse peritoneal or retroperitoneal tumor from the following histologies: adenocarcinoma of the gastrointestinal tract, desmoplastic round cell tumor, late stage neuroblastoma, ovarian germ cell, sarcoma, adrenocorticocarcinoma, Wilms', rhabdomyosarcoma. (target groups: desmoplastic small round cell tumor (DSRCT), neuroblastoma, and recurrent tumors). If tumors are outside the abdominal cavity, the tumors must be controllable.
- All patients must have refractory or recurrent tumors with no known curative treatment options.
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled.
- Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 mm thickness per tumor deposit
- Patients must have minimum expected duration of survival of greater than 6 weeks
- Patients must not have any systemic illness which precludes them from being an operative candidate. This includes but is not limited to sepsis, liver failure, pregnancy, lactating females.
- Patients must have fully intact mental status and normal neurologic abilities.
- Patients must have adequate renal function (serum creatinine </= 1.5 without history dialysis or renal failure)
- Patients will be eligible if the white blood count (WBC) is > or =2,000/ul or Absolute neutrophil count (ANC) is > or =1,500, or platelets are > or = 100,000/mm^3
- Patients will be eligible if serum total bilirubin and liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) are </= 2 times the upper limit of normal
- Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
- If tumors are outside the abdominal cavity, the tumors must be controllable.
Exclusion Criteria:
- Patients who have failed previous continuous hyperthermic intraperitoneal perfusion with platinum therapy will be ineligible
- Patients with tumors that are unable to be controlled outside the abdominal cavity will be ineligible
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Surgery + CHPP of Escalating Cisplatin
Abdominal Surgery + CHPP of Escalating Cisplatin (Starting dose of 100 mg/m^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.)