Recurrent Nasopharynx Carcinoma
Conditions
Keywords
Recurrent nasopharynx 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.
Interventions
DRUGEtoposide phosphate
Etoposide is one of three drugs used in the high-dose conditioning phase
DRUGCarboplatin
Carboplatin is one of the drugs used in the high-dose conditioning phase.
DRUGIfosfamide
Ifosfamide is one of the drugs used in the high-dose conditioning phase
PROCEDUREAutologous Stem Cell Transplantation
Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Tumor Response | 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. |
Countries
United States
Participant flow
Recruitment details
The protocol was terminated due to poor enrollment.
Participants by arm
| Arm | Count |
|---|---|
| High Dose Conditioning 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | High Dose Conditioning | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
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.
Time frame: 12 months after completion of treatment
Population: Due to only one subject being enrolled data analysis was completed