Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor
Advanced Cancers, Sarcoma
About this trial
This is an interventional treatment trial for Advanced Cancers focused on measuring Desmoplastic small round cell tumor, DSRCT, Hyperthermic peritoneal perfusion, HIPEC, Complete abdominal tumor excision, Extensive abdominal disease, Non-carcinoma tumors, Abdominal cavity, Cisplatin, Platinol-AQ, Platinol, CDDP, Diffuse peritoneal tumor, Retroperitoneal tumor, Ovarian germ cell, Wilms' tumor
Eligibility Criteria
Inclusion Criteria:
- Age greater than or equal to 1 years
- Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
- 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 cm thickness per tumor deposit
- Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist.
- 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, pregnant or lactating females.
- Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space.' Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist.
- Patients must have adequate renal function (serum creatinine </= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years of age)
- Patients will be eligible if the white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (ANC) is >/=1,500 and platelets are >/= 100,000/mm^3
- Patients will be eligible if serum total bilirubin and liver enzymes 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
Exclusion Criteria:
- 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 disease outside of the abdominal cavity which is uncontrolled
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
- Patients who have failed previous intraperitoneal platinum therapy will be ineligible
- Patients with Retroperitoneal Liposarcoma will be ineligible.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
HIPEC + Cisplatin
HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions. Cisplatin 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the Cisplatin.