Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Phase 3TerminatedNCT02137096

University of Florida1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Nasopharynx Carcinoma

Interventions

Etoposide phosphateDRUG

Etoposide is one of three drugs used in the high-dose conditioning phase

CarboplatinDRUG

Carboplatin is one of the drugs used in the high-dose conditioning phase.

IfosfamideDRUG

Ifosfamide is one of the drugs used in the high-dose conditioning phase

Eligibility

Sex: ALLMin age: 2 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

UF Health Shands Hospital

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months after completion of treatment

Data from ClinicalTrials.gov

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