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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

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.

Condition or disease Intervention/treatment Phase
Recurrent Nasopharynx Carcinoma Drug: Etoposide phosphate Drug: Carboplatin Drug: Ifosfamide Procedure: Autologous Stem Cell Transplantation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Actual Study Start Date : June 2014
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017


Arm Intervention/treatment
Experimental: High Dose Conditioning
Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137096


Locations
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United States, Florida
UF Health Shands Hospital
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: John Fort, MD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02137096     History of Changes
Other Study ID Numbers: IRB201400316
PEDS008 ( Other Identifier: University of Florida )
First Posted: May 13, 2014    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019
Last Verified: May 2019

Keywords provided by University of Florida:
Recurrent nasopharynx carcinoma

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents