Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
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 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)