Recurrent Nasopharynx CarcinomaPhase 3NCT02137096
Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
A Phase 3 study testing Etoposide phosphate, Carboplatin and Ifosfamide in people with Recurrent Nasopharynx Carcinoma, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Recurrent Nasopharynx Carcinoma
- What is being tested?
- Etoposide phosphate, Carboplatin and Ifosfamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 9 May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues
- Pregnancy
- Breast-feeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Hospital
Gainesville, Florida, 32610
About this study
Official title: High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
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.
Read the 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.
- Conditions
- Recurrent Nasopharynx Carcinoma
- Being tested
- Etoposide phosphate, Carboplatin, Ifosfamide, Autologous Stem Cell Transplantation
- Keywords
- Recurrent nasopharynx carcinoma
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoposide phosphateDrug
Also called Etopophos, Toposar
Etoposide is one of three drugs used in the high-dose conditioning phase
CarboplatinDrug
Also called Paraplatin
Carboplatin is one of the drugs used in the high-dose conditioning phase.
IfosfamideDrug
Also called Ifex
Ifosfamide is one of the drugs used in the high-dose conditioning phase
Autologous Stem Cell TransplantationProcedure or surgery
Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Conditioning | Experimental | Single arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation Receives: Drug: Etoposide phosphate; Drug: Carboplatin; Drug: Ifosfamide; Procedure: Autologous Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJun 2014
- Primary completion9 May 2017
- Study completion9 May 2017
Why it stopped: This is a rare disease, and enrollment was poor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Nasopharynx CarcinomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Fort, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137096
- Sponsor's protocol ID
- IRB201400316
- Other IDs
- PEDS008
- Status last verified
- May 2019
- First submitted
- 9 May 2014
- Last updated
- 24 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02137096
- Acronym / sponsor ID
- IRB201400316
- Conditions
- Recurrent Nasopharynx Carcinoma
- Keywords
- Recurrent nasopharynx carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is a rare disease, and enrollment was poor.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Dose Conditioning | Experimental | Drug: Etoposide phosphate, Drug: Carboplatin, Drug: Ifosfamide, Procedure: Autologous Stem Cell TransplantationSingle arm - receives high dose Etoposide phosphate, Ifosfamide, and Carboplatin followed by Autologous Stem Cell Transplantation |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues
- Pregnancy
- Breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoposide phosphateAlso: Etopophos, ToposarEtoposide is one of three drugs used in the high-dose conditioning phase | Drug | High Dose Conditioning |
| CarboplatinAlso: ParaplatinCarboplatin is one of the drugs used in the high-dose conditioning phase. | Drug | High Dose Conditioning |
| IfosfamideAlso: IfexIfosfamide is one of the drugs used in the high-dose conditioning phase | Drug | High Dose Conditioning |
| Autologous Stem Cell TransplantationAutologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm. | Procedure or surgery | High Dose Conditioning |
Primary outcome
Evaluate the Tumor Response
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fort, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoposide phosphate, Carboplatin and Ifosfamide in people with Recurrent Nasopharynx Carcinoma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Tumor Response (time frame: 12 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.