Nasopharyngeal CarcinomaPhase 1NCT00431210
Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
A Phase 1 study testing Epstein-Barr virus-specific adoptive T-cells immunotherapy in people with Nasopharyngeal Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Epstein-Barr virus-specific adoptive T-cells immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to 26 Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven NPC of any WHO grade, associated with EBV documented by the presence of EBER by in situ hybridization in the tumor. This must be confirmed by pathology review at Brigham and Women's Hospital.
- Incurable NPC as defined by: relapsed or progressive disease after initial treatment with no potentially curative option; NPC with metastasis
- Recovery from toxicity from any prior NPC therapy to grade 1 or better (CTCACE v.3.0)
- 18 years of age or older
- Evaluable disease, according to RECIST
- ECOG performance status of 0-1
- Adequate bone marrow, liver and renal function
Who cannot join
- Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
- Chemotherapy for NPC within 2 weeks of enrollment
- Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
- Uncontrolled central nervous system metastases
- Acute hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of systemic corticosteroids
- Autoimmune disease that is active and requires current therapy
Show all 11Show fewer
- Active, uncontrolled, serious infection
- Incomplete healing from previous major surgery
- Significant history of uncontrolled cardiac disease
- Women who have a positive B-hCG test or are breastfeeding
- Any concurrent chemotherapy or other concurrent investigational agent not part of this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. EBV immunotherapy product is made with white blood cells from the participants body that are collected intravenously. This EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy products have been used in several research studies for NPC. Information from these studies suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.
Read the detailed description
- The first step in this research study is the peripheral blood collection. Approximately 60-90cc's will be collected intravenously and used to prepare the EBV immunotherapy product. It takes about 12 weeks to make the EBV immunotherapy product. During this time, the participant will receive standard of care as prescribed by their doctor.
- The EBV immunotherapy product will be made at a laboratory at the Connell \& O'Reilly Families Cell and Manipulation Core Facility at the Dana-Farber Cancer Institute. The EBV immunotherapy product will contain T-cells that may react against your EBV-related tumor.
- A small amount of the EBV product will be used for research studies that will investigate components of the immune system that might be important in effective immunotherapy for NPC.
- EBV immunotherapy product will be given to the participant intravenously (infusion) on the first day of the research study. Fourteen days later, the participant will receive infusion #2. After infusion #2, the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the tumor. If the research doctor thinks the participant will benefit from a third infusion then they may receive one.
- Before each infusion of EBV immunotherapy product, a physical examination and blood tests will be performed. During the active treatment phase of this research study, a physical exam and blood tests will be done every 1-2 weeks.
- Before each infusion of EBV immunotherapy product, the research doctor may do a fiberoptic exam of the participants nasopharynx by using a flexible scop to visualize the tumor.
- At 8 weeks post-infusion, we will evaluate the tumor by using a CT scan and/or MRI. We will also perform a PET or PET/CT scan if the research doctor feels it is necessary. We may do a chest CT scan to see if the tumor has spread to the lungs and an abdominal/pelvic CT scan or MRI if the participant has symptoms that suggesting that there may be tumor in the liver, or a bone scan to see if there is tumor in the bones.
- In addition to this study, the research doctor may ask permission to participate in optional research studies. We would like the participants permission to take a biopsy of the tumor after they have received infusion #2. The biopsy will be done by a surgeon who will review the risks of the procedure.
- The participant will return to the clinic for a follow-up visit where the response of the tumor will be evaluated, blood tests and a physical exam will be performed at the following intervals: for the first 2 months after the final infusion, every 2-4 weeks; for month 4 to month 12 after the final infusion, every 2 months; for the second year after the final infusion, every 3 months.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Epstein-Barr virus-specific adoptive T-cells immunotherapy
- Keywords
- NPC, EPV
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epstein-Barr virus-specific adoptive T-cells immunotherapyBiological
Given intravenously on Day 1 and Day 14
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine | Experimental | Epstein-Barr virus-specific adoptive T-cells immunotherapy given intravenously on Days 1 and 14 Receives: Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility and safety of generating and administrating and EBV-specific adoptive T cell in participants with incurable locoregional relapsed and/or distant metastatic EBV-associated NPC.
Measured: 2 years
Secondary outcomes (3)
The ability to collect specimens and measure potential biologic correlate of response to therapy
Measured: 2 years
time to progression in this patient population
Measured: 2 years
median duration of response and median overall survival in this cohort of participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completion30 Jun 2015
- Study completion26 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Jochen Lorch, MD, Dana-Farber Cancer Institute
- Investigators
- Jochen Lorch, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431210
- Sponsor's protocol ID
- 06-179
- Status last verified
- Apr 2017
- First submitted
- 2 Feb 2007
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to share IPD. Cumulative results will be posted and published.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00431210
- Acronym / sponsor ID
- 06-179
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- NPC, EPV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Feb 2007
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of making and giving Epstein-Barr virus (EBV) immunotherapy products to subjects with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the body. EBV immunotherapy product is made with white blood cells from the participants body that are collected intravenously. This EBV immunotherapy product may stop cancer cells from growing abnormally. EBV immunotherapy products have been used in several research studies for NPC. Information from these studies suggests the EBV immunotherapy products may stop the growth of NPC in some subjects.
Detailed description
- The first step in this research study is the peripheral blood collection. Approximately 60-90cc's will be collected intravenously and used to prepare the EBV immunotherapy product. It takes about 12 weeks to make the EBV immunotherapy product. During this time, the participant will receive standard of care as prescribed by their doctor.
- The EBV immunotherapy product will be made at a laboratory at the Connell \& O'Reilly Families Cell and Manipulation Core Facility at the Dana-Farber Cancer Institute. The EBV immunotherapy product will contain T-cells that may react against your EBV-related tumor.
- A small amount of the EBV product will be used for research studies that will investigate components of the immune system that might be important in effective immunotherapy for NPC.
- EBV immunotherapy product will be given to the participant intravenously (infusion) on the first day of the research study. Fourteen days later, the participant will receive infusion #2. After infusion #2, the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the tumor. If the research doctor thinks the participant will benefit from a third infusion then they may receive one.
- Before each infusion of EBV immunotherapy product, a physical examination and blood tests will be performed. During the active treatment phase of this research study, a physical exam and blood tests will be done every 1-2 weeks.
- Before each infusion of EBV immunotherapy product, the research doctor may do a fiberoptic exam of the participants nasopharynx by using a flexible scop to visualize the tumor.
- At 8 weeks post-infusion, we will evaluate the tumor by using a CT scan and/or MRI. We will also perform a PET or PET/CT scan if the research doctor feels it is necessary. We may do a chest CT scan to see if the tumor has spread to the lungs and an abdominal/pelvic CT scan or MRI if the participant has symptoms that suggesting that there may be tumor in the liver, or a bone scan to see if there is tumor in the bones.
- In addition to this study, the research doctor may ask permission to participate in optional research studies. We would like the participants permission to take a biopsy of the tumor after they have received infusion #2. The biopsy will be done by a surgeon who will review the risks of the procedure.
- The participant will return to the clinic for a follow-up visit where the response of the tumor will be evaluated, blood tests and a physical exam will be performed at the following intervals: for the first 2 months after the final infusion, every 2-4 weeks; for month 4 to month 12 after the final infusion, every 2 months; for the second year after the final infusion, every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological/Vaccine | Experimental | Biological: Epstein-Barr virus-specific adoptive T-cells immunotherapyEpstein-Barr virus-specific adoptive T-cells immunotherapy given intravenously on Days 1 and 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven NPC of any WHO grade, associated with EBV documented by the presence of EBER by in situ hybridization in the tumor. This must be confirmed by pathology review at Brigham and Women's Hospital.
- Incurable NPC as defined by: relapsed or progressive disease after initial treatment with no potentially curative option; NPC with metastasis
- Recovery from toxicity from any prior NPC therapy to grade 1 or better (CTCACE v.3.0)
- 18 years of age or older
- Evaluable disease, according to RECIST
Key exclusion criteria (11 listed)
- Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks
- Chemotherapy for NPC within 2 weeks of enrollment
- Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
- Uncontrolled central nervous system metastases
- Acute hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of systemic corticosteroids
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 |
|---|---|---|
| Epstein-Barr virus-specific adoptive T-cells immunotherapyGiven intravenously on Day 1 and Day 14 | Biological | Biological/Vaccine |
Primary outcome
The feasibility and safety of generating and administrating and EBV-specific adoptive T cell in participants with incurable locoregional relapsed and/or distant metastatic EBV-associated NPC.
Time frame: 2 years
3 secondary outcomes
The ability to collect specimens and measure potential biologic correlate of response to therapy
Time frame: 2 years
time to progression in this patient population
Time frame: 2 years
median duration of response and median overall survival in this cohort of participants.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No. There are no plans to share IPD. Cumulative results will be posted and published.
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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.
Jochen Lorch, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epstein-Barr virus-specific adoptive T-cells immunotherapy in people with Nasopharyngeal Carcinoma, run by Dana-Farber Cancer Institute at 2 sites 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The feasibility and safety of generating and administrating and EBV-specific adoptive T cell in participants with incurable locoregional relapsed and/or distant metastatic EBV-associated NPC. (time frame: 2 years). 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 18 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.