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

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008

Sponsored by: 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 (40°C) 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

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

Drug Information available for:   Cisplatin   

U.S. FDA Resources

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

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

Primary Outcome Measures:
  • To find the highest tolerable dose of cisplatin given to pediatric patients undergoing extensive surgery to remove all visible tumor from the abdominal cavity. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

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
1: 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.
Procedure: Abdominal Surgery
Surgical removal of abdominal tumors.

Show detailed description  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

Contacts
Contact: Andrea Hayes-Jordan, MD     713-792-6620    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Andrea Hayes-Jordan, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Andrea Hayes-Jordan, MD     U.T. M.D. Anderson Cancer Center    
  More Information


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

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Andrea Hayes-Jordan, MD/Assistant Professor )
Study ID Numbers:   2005-0917
First Received:   February 15, 2007
Last Updated:   November 13, 2008
ClinicalTrials.gov Identifier:   NCT00436657
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Adrenocortical carcinoma
Adrenal Gland Diseases
Urogenital Neoplasms
Urologic Neoplasms
Retroperitoneal Neoplasms
Neoplasms, Connective and Soft Tissue
Peritoneal Diseases
Neuroepithelioma
Kidney Diseases
Adrenal Cortex Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Renal cancer
Carcinoma
Neuroectodermal Tumors
Sarcoma
Gastrointestinal Neoplasms
Adrenal Cortex Diseases
Neoplasms, Glandular and Epithelial
Gastrointestinal Diseases
Gonadal Disorders
Ovarian Diseases
Kidney cancer
Neuroblastoma
Soft tissue sarcomas

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Myosarcoma
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Body Temperature Changes
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Neuroepithelial
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on November 20, 2008




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