Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

University of Florida

Status and phase: Terminated; Phase 3

Conditions: Recurrent Nasopharynx Carcinoma

Treatments: Drug: Carboplatin; Procedure: Autologous Stem Cell Transplantation; Drug: Ifosfamide; Drug: Etoposide phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02137096

IRB201400316

PEDS008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 2 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

High Dose Conditioning

Experimental group

Description:

Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation

Treatment:

Drug: Etoposide phosphate

Procedure: Autologous Stem Cell Transplantation

Drug: Ifosfamide

Drug: Carboplatin