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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00436657
First received: February 15, 2007
Last updated: March 29, 2012
Last verified: March 2012
  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:

  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)

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 1

Study Type: Interventional
Study Design: 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:


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
Abdominal Surgery + CHPP of Escalating 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.)
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:

  1. Age greater than or equal to 3 and less than or equal to 18 years
  2. 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.
  3. All patients must have refractory or recurrent tumors with no known curative treatment options.
  4. 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.
  5. 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
  6. Patients must have minimum expected duration of survival of greater than 6 weeks
  7. 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.
  8. Patients must have fully intact mental status and normal neurologic abilities.
  9. Patients must have adequate renal function (serum creatinine </= 1.5 without history dialysis or renal failure)
  10. 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
  11. 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
  12. 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
  13. If tumors are outside the abdominal cavity, the tumors must be controllable.

Exclusion Criteria:

  1. Patients who have failed previous continuous hyperthermic intraperitoneal perfusion with platinum therapy will be ineligible
  2. Patients with tumors that are unable to be controlled outside the abdominal cavity will be ineligible
  3. Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
  4. 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
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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:
No publications provided

Responsible Party: 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: March 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Wilms' Tumor
Children
Pediatric
Peritoneal Tumor
Retroperitoneal Tumor
Gastrointestinal Adenocarcinoma
Desmoplastic Round Cell Tumor
Neuroblastoma
Ovarian Germ Cell
Sarcoma
Adrenocorticocarcinoma
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:
Wilms Tumor
Neoplasms
Adenocarcinoma
Sarcoma
Neuroblastoma
Rhabdomyosarcoma
Ovarian Neoplasms
Fever
Adrenocortical Carcinoma
Desmoplastic Small Round Cell Tumor
Peritoneal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Retroperitoneal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 16, 2014