Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor

Completed · Phase 2

Conditions studied: Advanced Cancers, Sarcoma

In brief

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.

Key facts

Study ID

NCT01277744

Run by

M.D. Anderson Cancer Center

People needed

22

Starts

2011-05-09

Expected to finish

2018-02-16

Last updated by the study team

2020-01-13

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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