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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02137096
Other study ID # IRB201400316
Secondary ID PEDS008
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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