Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00436657

Purpose

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:

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
To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)

Condition	Intervention	Phase
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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma Help Me Understand Genetics

MedlinePlus related topics: Cancer Fever Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma Wilms' Tumor

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Maximum Tolerated Dose (MTD) of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin in children with peritoneal cancer [ Time Frame: Assessed during treatment and post surgery through hospital stay (estimated 5 days) followed one month later. ] [ Designated as safety issue: Yes ]
The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

Enrollment:	10
Study Start Date:	February 2007
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Surgery + CHPP of Escalating Cisplatin	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. Other Names: Platinol®-AQ Platinol® CDDP Abdominal Wash hyperthermic perfusion Procedure: Abdominal Surgery Surgical removal of abdominal tumors. Other Name: cytoreductive surgery

Arms

Assigned Interventions

Experimental: Surgery + CHPP of Escalating Cisplatin

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.

Other Names:

Platinol®-AQ
Platinol®
CDDP
Abdominal Wash
hyperthermic perfusion

Procedure: Abdominal Surgery

Surgical removal of abdominal tumors.

Other Name: cytoreductive surgery

Show Detailed Description

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 to1 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 WBC is > or =2,000/ul or ANC is > or =1,500, or platelets are > or = 100,000/mm^3
Patients will be eligible if serum total bilirubin and liver enzymes (ALT or AST) 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 Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436657

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Andrea Hayes-Jordan, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Andrea Hayes-Jordan, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00436657 History of Changes
Other Study ID Numbers:	2005-0917
Study First Received:	February 15, 2007
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Children
Pediatric
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

Additional relevant MeSH terms:

Adenocarcinoma
Neoplasms
Carcinoma
Fever
Gastrointestinal Neoplasms
Digestive System Neoplasms
Wilms Tumor
Neuroblastoma
Ovarian Neoplasms
Peritoneal Neoplasms
Retroperitoneal Neoplasms
Rhabdomyosarcoma
Adrenocortical Carcinoma
Desmoplastic Small Round Cell Tumor
Peritoneal Diseases

Sarcoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012