Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma

• Sponsor: University of Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02137096
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 35.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Nasopharynx Carcinoma	Drug: Etoposide phosphate; Drug: Carboplatin; Drug: Ifosfamide; Procedure: Autologous Stem Cell Transplantation	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: May 9, 2017
• Actual Study Completion Date: May 9, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: High Dose Conditioning Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation

Drug: Etoposide phosphate; Etoposide is one of three drugs used in the high-dose conditioning phase; Other Names: Etopophos Toposar ; Drug: Carboplatin; Carboplatin is one of the drugs used in the high-dose conditioning phase.; Other Names: Paraplatin ; Drug: Ifosfamide; Ifosfamide is one of the drugs used in the high-dose conditioning phase; Other Names: Ifex ; Procedure: Autologous Stem Cell Transplantation; Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health Shands Hospital	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: John Fort, MD, University of Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2017

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02137096
• Other Study ID Numbers: IRB201400316; PEDS008
• First Posted: May 13, 2014
• Last Update Posted: Jun 24, 2019
• Last Verified: May 1, 2019

• Keywords provided by University of Florida: Recurrent nasopharynx carcinoma
• Additional relevant MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Recurrence; Carboplatin; Etoposide; Ifosfamide; Etoposide phosphate

Study Results

Participant Flow

Recruitment Details	The protocol was terminated due to poor enrollment.

Arm/Group Title	High Dose Conditioning
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	High Dose Conditioning
Arm/Group Description	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.
Overall Participants	1
Age (Count of Participants)
<=18 years	1 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Evaluate the Tumor Response
Description	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

Outcome Measure Data

Analysis Population Description

Due to only one subject being enrolled data analysis was completed

Arm/Group Title	High Dose Conditioning
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	6 months
Arm/Group Title	High Dose Conditioning
Arm/Group Description	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.
All Cause Mortality
	High Dose Conditioning
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	High Dose Conditioning
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Blood and lymphatic system disorders
Grade III Hypophosphatemia	1/1 (100%)	1
Gastrointestinal disorders
Grade III Mucositis	1/1 (100%)	1
Immune system disorders
Sepsis	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	High Dose Conditioning
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

Early termination leading to no subject data analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.