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Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02137096
Recruitment Status : Terminated (This is a rare disease, and enrollment was poor.)
First Posted : May 13, 2014
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Nasopharynx Carcinoma
Interventions Drug: Etoposide phosphate
Drug: Carboplatin
Drug: Ifosfamide
Procedure: Autologous Stem Cell Transplantation
Enrollment 1
Recruitment Details The protocol was terminated due to poor enrollment.
Pre-assignment Details  
Arm/Group Title High Dose Conditioning
Hide Arm/Group Description

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

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

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

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

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

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title High Dose Conditioning
Hide Arm/Group Description

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

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

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

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

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

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Evaluate the Tumor Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Due to only one subject being enrolled data analysis was completed
Arm/Group Title High Dose Conditioning
Hide Arm/Group Description:

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

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

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

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

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Conditioning
Hide Arm/Group Description

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

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

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

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

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

All-Cause Mortality
High Dose Conditioning
Affected / at Risk (%)
Total   0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Conditioning
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Grade III Hypophosphatemia   1/1 (100.00%)  1
Gastrointestinal disorders   
Grade III Mucositis   1/1 (100.00%)  1
Immune system disorders   
Sepsis   1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Conditioning
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Early termination leading to no subject data analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: John Fort, MD
Organization: University of Florida
Phone: 352-273-9120
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02137096     History of Changes
Other Study ID Numbers: IRB201400316
PEDS008 ( Other Identifier: University of Florida )
First Submitted: May 9, 2014
First Posted: May 13, 2014
Results First Submitted: May 29, 2019
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019