Nasopharyngeal CancerPhase 1NPC-CTLNCT00706316
Administration of Epstein Barr Virus - Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer
A Phase 1 study testing EBV-Specific CTLs and CD45 Mab in people with Nasopharyngeal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other organs, treatment options are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- EBV-Specific CTLs and CD45 Mab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Nov 2012
- 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
- Any patient with EBV positive NPC, with recurrent and/or metastatic disease
- Patients with a life expectancy > 3 months.
- Patients with an ECOG performance status of 0, 1 or 2
- No severe intercurrent infection.
- Patients who are able to give informed consent.
- Patients with:
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- bilirubin <2x normal,
- SGOT (AST) and SGPT (ALT) <3x normal,
- Hgb >80 g/L,
- absolute neutrophil count (ANC) > 1.5 x 109/L,
- and platelets > 100 x 109/L.
- Patients with a creatinine <2x normal for age
- Patients should have been off any chemotherapy or other investigational therapy for at least 4 weeks prior to entry in this study.
- Patients should have completed any prior radiation therapy for at least 3 weeks prior to entry in this study. Exception may be made, however, for low-dose, non-myelosuppressive radiotherapy, but this must be discussed with Principal Investigator(s).
- All patients must have measurable disease, with minimum indicator lesions size as follows:
- CT scan > 2 cm (or > 1 cm if spiral CT scan is used)
- Ultrasound > 2 cm
- Chest x-ray > 2 cm
- Physical exam > 1 cm (skin lesions, nodes, soft tissue masses)
Who cannot join
- Patients with a life expectancy of < 3 months.
- Patients with an ECOG performance status of >2.
- Patients with a severe intercurrent infection.
- Patients unable or unwilling to give informed consent.
- Patients with a bilirubin >2x normal.
- SGOT (AST) and SGPT (ALT) >3x normal.
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- Patients with a creatinine >2x normal for age
- Patients with Hgb < 80 g/L, absolute neutrophil count (ANC) < 1.5 x 109/L, and platelets < 100 x 109/L.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. Lactating women are excluded from this study. Patients and their partners must use an effective birth control method during the study and for 6 months after. Effective birth control methods are: total abstinence, oral contraceptives, intrauterine devices, contraceptive implants under the skin or contraceptive injections. If one of these methods cannot be used, contraceptive foam with a condom is allowed. The male partner should use a condom.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial Evaluating the Administration of Epstein Barr Virus (EBV)-Specific Cytotoxic T-Lymphocytes (CTLs) to Patients With Recurrent or Metastatic EBV-Positive Nasopharygneal Cancer (NPC)
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other organs, treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the development of NPC, and studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.
Read the detailed description
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy. However, the treatment of this cancer can lead to later complications, including other cancers, and if NPC relapses or spreads to other organs, the treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs.
Epstein-Barr Virus (EBV) is known to play a role in the development of NPC in individuals, especially those with a compromised immune system. Studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- EBV-Specific CTLs and CD45 Mab
- Keywords
- Nasopharygneal Cancer, Epstein Barr Virus, (EBV)-Specific Cytotoxic T-Lymphocytes, Recurrent, Metastatic, EBV-Positive Nasopharygneal Cancer
- Medical subject headings
- Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-Specific CTLs and CD45 MabBiological
One time infusion (IV) at one of the following dose levels:
Dose level I: 5 x 107 cells/m2
Dose level II: 1 x 108 cells/m2
Dose level III: 2 x 108 cells/m2
| Study group | Role | What they receive |
|---|---|---|
| EBV-Specific CTLs and CD45 Mab | Experimental | A dose escalation schema will be employed. Three to six patients will be treated at each of the following dose levels with EBV-Specific CTLs and CD45 Mab: Dose Level I: 2 x 10^7 cells/m2. Dose Level II: 5 x 10^7 cells/m2. Dose Level III: 1 x 10^8 cells/m2. Dose escalation decisions will be made after review of the data from the current dose level. There will be no intra-patient escalation. An additional 6-10 patients with measurable disease will be treated at the recommended phase II dose to expand the experience at this dose level. Receives: Biological: EBV-Specific CTLs and CD45 Mab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of autologous EBV-specific CTLs in patients with nasopharyngeal cancer
Measured: 24 months
Secondary outcomes (1)
To obtain information on the expansion, persistence and anti-tumor effects of EBV-specific CTL lines in patients with nasopharyngeal cancer
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, University Health Network - Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706316
- Sponsor's protocol ID
- NPC-CTL
- Acronym
- NPC-CTL
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2008
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Evaluating the Administration of Epstein Barr Virus (EBV)-Specific Cytotoxic T-Lymphocytes (CTLs) to Patients With Recurrent or Metastatic EBV-Positive Nasopharygneal Cancer (NPC)
- ClinicalTrials.gov ID
- NCT00706316
- Acronym / sponsor ID
- NPC-CTL / NPC-CTL
- Conditions
- Nasopharyngeal Cancer
- Keywords
- Nasopharygneal Cancer, Epstein Barr Virus, (EBV)-Specific Cytotoxic T-Lymphocytes, Recurrent, Metastatic, EBV-Positive Nasopharygneal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jun 2008 (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.
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy; however, if NPC relapses or spreads to other organs, treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs. Epstein-Barr Virus (EBV) is known to play a role in the development of NPC, and studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.
Detailed description
Nasopharyngeal cancer (NPC) is a cancer that starts at the back of the nose. Without distant spread, NPC is sensitive to radiotherapy and chemotherapy. However, the treatment of this cancer can lead to later complications, including other cancers, and if NPC relapses or spreads to other organs, the treatment options are limited. This grant proposes to evaluate the safety and tolerability of a novel treatment for patients with NPC that has either relapsed or spread to distant organs.
Epstein-Barr Virus (EBV) is known to play a role in the development of NPC in individuals, especially those with a compromised immune system. Studies have shown that NPC tumor cells express proteins that are related to EBV. Some of these proteins can trigger a response from the immune system, specifically the activation of cytotoxic T lymphocytes (CTLs), a type of immune cell that might exert anti-tumor effects. In this project, we will take blood from NPC patients, generate CTLs targeted against EBV, and re-infuse these back into patients in an attempt to achieve anti-tumor activity. Patients will also receive an antibody called CD45 Mab prior to CTL infusion in order to allow for better expansion of the infused CTLs in the patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-Specific CTLs and CD45 Mab | Experimental | Biological: EBV-Specific CTLs and CD45 MabA dose escalation schema will be employed. Three to six patients will be treated at each of the following dose levels with EBV-Specific CTLs and CD45 Mab: Dose Level I: 2 x 10^7 cells/m2. Dose Level II: 5 x 10^7 cells/m2. Dose Level III: 1 x 10^8 cells/m2. Dose escalation decisions will be made after review of the data from the current dose level. There will be no intra-patient escalation. An additional 6-10 patients with measurable disease will be treated at the recommended phase II dose to expand the experience at this dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Any patient with EBV positive NPC, with recurrent and/or metastatic disease
- Patients with a life expectancy > 3 months.
- Patients with an ECOG performance status of 0, 1 or 2
- No severe intercurrent infection.
- Patients who are able to give informed consent.
Key exclusion criteria (9 listed)
- Patients with a life expectancy of < 3 months.
- Patients with an ECOG performance status of >2.
- Patients with a severe intercurrent infection.
- Patients unable or unwilling to give informed consent.
- Patients with a bilirubin >2x normal.
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 |
|---|---|---|
| EBV-Specific CTLs and CD45 MabOne time infusion (IV) at one of the following dose levels: Dose level I: 5 x 107 cells/m2 Dose level II: 1 x 108 cells/m2 Dose level III: 2 x 108 cells/m2 | Biological | EBV-Specific CTLs and CD45 Mab |
Primary outcome
To determine the safety of autologous EBV-specific CTLs in patients with nasopharyngeal cancer
Time frame: 24 months
1 secondary outcome
To obtain information on the expansion, persistence and anti-tumor effects of EBV-specific CTL lines in patients with nasopharyngeal cancer
Time frame: 36 months
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 10 Jul 2015.
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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.
Lillian Siu, MD principal investigator
University Health Network - Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBV-Specific CTLs and CD45 Mab in people with Nasopharyngeal Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 19 inclusion and 9 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 10 Jul 2015. 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 Canada. 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?
To determine the safety of autologous EBV-specific CTLs in patients with nasopharyngeal cancer (time frame: 24 months). 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 10 Jul 2015.