Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Phase 3

Terminated

• Conditions: Recurrent Nasopharynx Carcinoma
• Interventions: Drug: Etoposide phosphate; Drug: Carboplatin; Drug: Ifosfamide; Procedure: Autologous Stem Cell Transplantation

• Registration Number: NCT02137096
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-13
• Study Start: 2014-06
• Primary Completion: 2017-05-09
• Study Completion: 2017-05-09
• Status Verified: 2019-05
• Results First Submitted: 2019-05-29
• Results First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-29
• Results First Posted: 2019-06-24
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Dose Conditioning	Etoposide phosphate	Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
High Dose Conditioning	Carboplatin	Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
High Dose Conditioning	Ifosfamide	Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
High Dose Conditioning	Autologous Stem Cell Transplantation	Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation

Primary Outcome Measures

Name	Time	Method
Evaluate the Tumor Response	12 months after completion of treatment	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.

Trial Locations

Locations (1)

UF Health Shands Hospital; 🇺🇸 Gainesville, Florida, United States