Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-05-09

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.

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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.

Conditions

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Recurrent Nasopharynx Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Dose Conditioning

Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation

Group Type EXPERIMENTAL

Etoposide phosphate

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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

Ifosfamide

Intervention Type DRUG

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

Autologous Stem Cell Transplantation

Intervention Type PROCEDURE

Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.

Interventions

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Etoposide phosphate

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

Intervention Type DRUG

Carboplatin

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

Intervention Type DRUG

Ifosfamide

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

Intervention Type DRUG

Autologous Stem Cell Transplantation

Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.

Intervention Type PROCEDURE

Other Intervention Names

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Etopophos Toposar Paraplatin Ifex

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