NCT00834093

Brief Summary

The purpose of this research study is to determine how effective and how safe it is to give an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal carcinoma (NPC) associated with EBV that has come back or spread to other parts of the participant's body. This is phase II study with the aim of establishing a baseline of efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

February 2, 2009

Results QC Date

May 9, 2023

Last Update Submit

June 27, 2023

Conditions

Nasopharyngeal Carcinoma

Keywords

Epstein-Barr VirusNPCEBVimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Best Overall Response Rate (ORR)

    ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

    Restaging scans were performed every 8 weeks on treatment up to 20 weeks.

Secondary Outcomes (3)

  • Time to Progression (TTP)

    Restaging scans were performed every 8 weeks until PD. Follow-up duration was up to 92 months.

  • Number of Participants With Grade 1-2 Fatigue Adverse Events," as Accurate and Appropriate

    Adverse events were assessed after each infusion treatment. Treatment duration was up to 66 months.

  • Overall Survival (OS)

    Participants were followed for survival per institutional practice until death or lost-to-follow-up. Follow-up duration was up to 92 months.

Study Arms (1)

EBV-stimulated cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy

EXPERIMENTAL

Eligible participants underwent a blood draw to obtain peripheral blood mononuclear cells (PBMCs) used for preparation of the immunotherapy product \[estimated preparation time 14-16 weeks\]. Participants received palliative chemotherapy for NPC as standard of care during the period required for T-cell production. Participants who achieved a partial response or better while receiving palliative chemotherapy continued to receive chemotherapy for 3 to 6 cycles and were only eligible for immunotherapy when progressive disease (PD) was confirmed. Each participant received a minimum of 2 EBV-CTL infusions, given 2 weeks apart, at doses of 1x108 cells/m2. A 3rd infusion was offered to participants 8-12 weeks after the 2nd infusion based on response, tolerability and sufficient immunotherapy product reserves.

Biological: Epstein-Barr Virus Specific Immunotherapy

Interventions

Epstein-Barr Virus Specific ImmunotherapyBIOLOGICAL
Also known as: Cell based vaccine
EBV-stimulated cytotoxic T-lymphocyte (EBV-CTL) Immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proven NPC of an WHO grade, associated with EBV infection documented by the presence of EBER expression by in situ hybridization in the tumor. Positive EBER staining from another institution must be confirmed by pathology review at Brigham and Women's Hospital. Other confirmation of EBV-associated disease is acceptable, such as EBV DNA in situ hybridization, if EBER analysis is not adequate
  • Incurable NPC
  • Recovery from toxicity from any prior NPC therapy to grade 1 or better
  • years of age or older
  • Evaluable or measurable disease, according to modified RECIST
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow, liver and renal function as outlined in protocol

You may not qualify if:

  • 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
  • Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids
  • Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
  • Active uncontrolled serious infection
  • Women of child-bearing potential who have a positive pregnancy test or are breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Huang J, Fogg M, Wirth LJ, Daley H, Ritz J, Posner MR, Wang FC, Lorch JH. Epstein-Barr virus-specific adoptive immunotherapy for recurrent, metastatic nasopharyngeal carcinoma. Cancer. 2017 Jul 15;123(14):2642-2650. doi: 10.1002/cncr.30541. Epub 2017 Feb 21.

    PMID: 28222215RESULT

MeSH Terms

Conditions

Nasopharyngeal CarcinomaEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Limitations and Caveats

The number of evaluable participants did not meet protocol objectives (n=13 versus target n=18).

Results Point of Contact

Title
Dr. Glenn Hanna
Organization
Dana-Farber Cancer Institute
GJHANNA@PARTNERS.ORG
617.632.6799

Study Officials

  • Glenn Hanna, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

February 1, 2017

Last Updated

June 28, 2023

Results First Posted

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

There are no plans to share IPD. Cumulative results will be posted and published.

Locations

US(2)