Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer

Completed · Phase 1

Conditions studied: Peritoneal Neoplasms, Retroperitoneal Neoplasms, Gastrointestinal Neoplasms, Adenocarcinoma, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Adrenocortical Carcinoma, Wilms Tumor, Rhabdomyosarcoma, Desmoplastic Small Round Cell Tumor

In brief

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 selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in adult clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma. This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled. Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases, this study will evaluate the safety of elevated temperature (40oC) with intraperitoneal cisplatin chemotherapy. Primary Objectives: 1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors 2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials 3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)

Key facts

Study ID: NCT00436657
Run by: M.D. Anderson Cancer Center
People needed: 10
Starts: 2007-02-01
Expected to finish: 2011-04-01
Last updated by the study team: 2012-04-02

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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