NCT02137096

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 24, 2019

Completed
Last Updated

June 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

May 9, 2014

Results QC Date

May 29, 2019

Last Update Submit

May 29, 2019

Conditions

Recurrent Nasopharynx Carcinoma

Keywords

Recurrent nasopharynx carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

High Dose Conditioning

EXPERIMENTAL

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

Drug: Etoposide phosphateDrug: CarboplatinDrug: IfosfamideProcedure: Autologous Stem Cell Transplantation

Interventions

Etoposide phosphateDRUG

Etoposide is one of three drugs used in the high-dose conditioning phase

Also known as: Etopophos, Toposar
High Dose Conditioning
CarboplatinDRUG

Carboplatin is one of the drugs used in the high-dose conditioning phase.

Also known as: Paraplatin
High Dose Conditioning
IfosfamideDRUG

Ifosfamide is one of the drugs used in the high-dose conditioning phase

Also known as: Ifex
High Dose Conditioning
Autologous Stem Cell TransplantationPROCEDURE

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

High Dose Conditioning

Eligibility Criteria

Age2 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues
  • Pregnancy
  • Breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

etoposide phosphateEtoposideCarboplatinIfosfamide

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCoordination ComplexesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Early termination leading to no subject data analyzed

Results Point of Contact

Title
John Fort, MD
Organization
University of Florida
john.fort@ufl.edu
352-273-9120

Study Officials

  • John Fort, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

June 1, 2014

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

June 24, 2019

Results First Posted

June 24, 2019

Record last verified: 2019-05

Locations

US(1)