Status:
COMPLETED
Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Peritoneal Neoplasms
Retroperitoneal Neoplasms
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief Summary
There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in childhood tumors. Once this advanced stage of disease is evident, survival is measured in weeks. The selec...
Detailed Description
Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, causing them to eventually die. Sodium thiosulfate is designed to bind-up any Cisplatin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00436657
Start Date
February 1 2007
End Date
April 1 2011
Last Update
April 2 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030