Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This is a pilot study to evaluate the response rates for patients undergoing high dose conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in children, adolescents, and young adults.

Detailed Description
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The use of high dose chemotherapy followed by autologous peripheral blood stem cell (PBSC) transplantation in recurrent nasopharyngeal carcinoma has shown promise when compared with standard chemotherapy. This study has been designed to evaluate response rates and toxicities associated with undergoing high dose conditioning with Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation support in the treatment of recurrent nasopharyngeal carcinoma in children, adolescents, and young adults.

Official Title
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High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Conditions
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Recurrent Nasopharynx Carcinoma

Intervention / Treatment
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* Drug: Etoposide phosphate
* Drug: Carboplatin
* Drug: Ifosfamide
* Procedure: Autologous Stem Cell Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma Documentation of previous treatment including conventional chemotherapy and/or radiation therapy as clinically appropriate Ages 2 to 30 years of age Negative serum pregnancy test if applicable Calculated creatinine clearance of greater than 60 mL/minute, serum creatinine of less than 12o micromoles/L, total bilirubin less than 2 mg/dL and aspartate aminotransferase (AST) must be less than twice the upper limit of normal Exclusion Criteria: Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues Pregnancy Breast-feeding women

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Conditioning<br>Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation | Drug: Etoposide phosphate<br>* Etoposide is one of three drugs used in the high-dose conditioning phase<br>* Other names: Toposar;Drug: Carboplatin<br>* Carboplatin is one of the drugs used in the high-dose conditioning phase.<br>* Other names: Paraplatin;Drug: Ifosfamide<br>* Ifosfamide is one of the drugs used in the high-dose conditioning phase<br>* Other names: Ifex;Procedure: Autologous Stem Cell Transplantation<br>* Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Tumor Response | To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults. | 12 months after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent nasopharynx carcinoma