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

NCT00436657 | Completed Phase 1

• 1 other identifier: 2005-0917
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
3. 3.To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)

Conditions

Peritoneal Neoplasms; Retroperitoneal Neoplasms; Gastrointestinal Neoplasms; Adenocarcinoma; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Adrenocortical Carcinoma; Wilms Tumor; Rhabdomyosarcoma; Desmoplastic Small Round Cell Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin in children with peritoneal cancer

  The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

  Assessed during treatment and post surgery through hospital stay (estimated 5 days) followed one month later.

Study Arms (1)

Surgery + CHPP of Escalating Cisplatin

EXPERIMENTAL

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; Procedure: Abdominal Surgery

Interventions

CHPP of Cisplatin DRUG

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.

Also known as: Platinol®-AQ, Platinol®, CDDP, Abdominal Wash, hyperthermic perfusion

Surgery + CHPP of Escalating Cisplatin

Abdominal Surgery PROCEDURE

Surgical removal of abdominal tumors.

Also known as: cytoreductive surgery

Surgery + CHPP of Escalating Cisplatin

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 to 1 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 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
• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Peritoneal Neoplasms; Retroperitoneal Neoplasms; Gastrointestinal Neoplasms; Adenocarcinoma; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Adrenocortical Carcinoma; Wilms Tumor; Rhabdomyosarcoma; Desmoplastic Small Round Cell Tumor; Neoplasms

Interventions

Cisplatin; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Neoplastic Syndromes, Hereditary; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myosarcoma; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Surgical Procedures, Operative

Study Officials

• Andrea Hayes-Jordan, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

US (1)