Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Recurrent Nasopharynx Carcinoma Clinical Trial

Official title:

High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02137096
• Other study ID #: IRB201400316
• Secondary ID: PEDS008
• Status: Terminated
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: May 9, 2017

Study information

• Verified date: May 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrent Nasopharynx Carcinoma

Intervention

Drug:
• 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

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

Locations

Country	Name	City	State
United States	UF Health Shands Hospital	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after completion of treatment