Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 9, 2014
First Posted Date  ICMJE May 13, 2014
Results First Submitted Date  ICMJE May 29, 2019
Results First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Evaluate the Tumor Response [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02137096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Treatment related Toxicity [ Time Frame: 60 months after treatment ]
To evaluate the toxicities associated with 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Official Title  ICMJE High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Nasopharynx Carcinoma
Intervention  ICMJE
  • Drug: Etoposide phosphate
    Etoposide is one of three drugs used in the high-dose conditioning phase
    Other Names:
    • Etopophos
    • Toposar
  • Drug: Carboplatin
    Carboplatin is one of the drugs used in the high-dose conditioning phase.
    Other Name: Paraplatin
  • Drug: Ifosfamide
    Ifosfamide is one of the drugs used in the high-dose conditioning phase
    Other Name: Ifex
  • Procedure: Autologous Stem Cell Transplantation
    Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
Study Arms  ICMJE Experimental: High Dose Conditioning
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
Interventions:
  • Drug: Etoposide phosphate
  • Drug: Carboplatin
  • Drug: Ifosfamide
  • Procedure: Autologous Stem Cell Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 13, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2014)
10
Actual Study Completion Date  ICMJE May 9, 2017
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02137096
Other Study ID Numbers  ICMJE IRB201400316
PEDS008 ( Other Identifier: University of Florida )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Fort, MD University of Florida
PRS Account University of Florida
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP