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Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Recurrent Nasopharynx Carcinoma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Etoposide phosphate
Carboplatin
Ifosfamide
Autologous Stem Cell Transplantation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Nasopharynx Carcinoma focused on measuring Recurrent nasopharynx carcinoma

Eligibility Criteria

2 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health Shands Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Dose Conditioning

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2014
Last Updated
May 29, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02137096
Brief Title
Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Official Title
High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
This is a rare disease, and enrollment was poor.
Study Start Date
June 2014 (Actual)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Nasopharynx Carcinoma
Keywords
Recurrent nasopharynx carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose Conditioning
Arm Type
Experimental
Arm Description
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
Intervention Type
Drug
Intervention Name(s)
Etoposide phosphate
Other Intervention Name(s)
Etopophos, Toposar
Intervention Description
Etoposide is one of three drugs used in the high-dose conditioning phase
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin is one of the drugs used in the high-dose conditioning phase.
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Ifex
Intervention Description
Ifosfamide is one of the drugs used in the high-dose conditioning phase
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplantation
Intervention Description
Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
Primary Outcome Measure Information:
Title
Evaluate the Tumor Response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fort, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

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