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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00436657 |
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:
Condition | Intervention | Phase |
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Peritoneal Neoplasms Retroperitoneal Neoplasms Gastrointestinal Neoplasms Adenocarcinoma Neuroblastoma Ovarian Neoplasms Sarcoma Adrenocortical Carcinoma Wilms Tumor Rhabdomyosarcoma Desmoplastic Small Round Cell Tumor |
Drug: CHPP of Cisplatin Procedure: Abdominal Surgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease |
Estimated Enrollment: | 18 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Surgery + CHPP of Escalating Cisplatin
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Drug: CHPP of Cisplatin
Starting dose of 100 mg/m^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.
Procedure: Abdominal Surgery
Surgical removal of abdominal tumors.
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Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Hayes-Jordan, MD | 713-792-6620 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Andrea Hayes-Jordan, MD |
Principal Investigator: | Andrea Hayes-Jordan, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Andrea Hayes-Jordan, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0917 |
Study First Received: | February 15, 2007 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00436657 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Peritoneal Tumor Retroperitoneal Tumor Gastrointestinal Adenocarcinoma Desmoplastic Round Cell Tumor Neuroblastoma Ovarian Germ Cell Sarcoma Adrenocorticocarcinoma Wilms' Tumor Rhabdomyosarcoma |
Desmoplastic Small Round Cell Tumor Recurrent Tumors Cisplatin Platinol®-AQ Platinol® CDDP Abdominal Wash Hyperthermic Perfusion Continuous Hyperthermic Peritoneal Perfusion CHPP |
Neuroectodermal Tumors, Primitive Adrenal Gland Diseases Urogenital Neoplasms Urologic Neoplasms Retroperitoneal Neoplasms Neoplasms, Connective and Soft Tissue Wilms' Tumor Peritoneal Diseases Neuroepithelioma Ovarian Cancer Kidney Diseases Adrenal Cortex Neoplasms Rhabdomyosarcoma Endocrine Gland Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Carcinoma Neuroectodermal Tumors Malignant Mesenchymal Tumor Sarcoma Gastrointestinal Neoplasms Adrenal Cortex Diseases Neoplasms, Glandular and Epithelial Urinary Tract Neoplasm Desmoplastic Small Round Cell Tumor Gastrointestinal Diseases Gonadal Disorders Ovarian Diseases Neuroblastoma |
Neuroectodermal Tumors, Primitive Physiological Effects of Drugs Adrenal Gland Diseases Urogenital Neoplasms Urologic Neoplasms Retroperitoneal Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Site Therapeutic Uses Peritoneal Diseases Kidney Diseases Adrenal Cortex Neoplasms Rhabdomyosarcoma Endocrine Gland Neoplasms Digestive System Neoplasms |
Myosarcoma Genital Neoplasms, Female Endocrine System Diseases Carcinoma Neuroectodermal Tumors Neoplasms Sarcoma Gastrointestinal Neoplasms Adrenal Cortex Diseases Neoplasms, Neuroepithelial Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial Neoplasms, Muscle Tissue Antineoplastic Agents Gastrointestinal Diseases |