Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor
Condition: Advanced Cancers; Sarcoma
MeSH terms: Desmoplastic Small Round Cell Tumor; Hyperthermia; Fever
Intervention: Hyperthermic Peritoneal Perfusion (HIPEC); Cisplatin
Intervention description: 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.; 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: 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

Summary:

      The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can
      help to control abdominal tumors in patients having surgery to remove the tumors. The safety
      of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 1 years

          2. 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.

          3. Radiologic workup must demonstrate that the disease is confined to the abdominal
             cavity

          4. 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

          5. 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.

          6. 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.

          7. 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.

          8. 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)

          9. 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

         10. Patients will be eligible if serum total bilirubin and liver enzymes are </=2 times
             the upper limit of normal

         11. 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:

          1. Patients will be ineligible if they have any concomitant cardiopulmonary disease which
             would place them at unacceptable risk for a major surgical procedure

          2. Patients will be ineligible if they have disease outside of the abdominal cavity which
             is uncontrolled

          3. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or
             greater (because of the potential neurotoxicity associated with platinum)

          4. Patients who have failed previous intraperitoneal platinum therapy will be ineligible

          5. Patients with Retroperitoneal Liposarcoma will be ineligible.