Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Epstein-Barr Virus-Related Cancer
A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
NCT01147991CI-TRIAL-00006348completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with Epstein-Barr virus and cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Nonneoplastic Condition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI CTCAE version 3.0)
- measure
- Occurrence of local skin reactions considered related to the vaccination
- measure
- Occurrence of drug-related systemic reactions (e.g., transient fever)
- measure
- Demonstration by ELIspot assays of the frequency of T-lymphocytes recognizing major histocompatibility complex (MHC) class I and II-restricted epitopes within EBNA1 and LMP2 in peripheral blood at sequential time-points before, during, and up to 9 mo ...
Secondary outcomes (1)
- measure
- Measurement of EBV-genome levels in plasma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy of a type typically associated with Epstein-Barr virus (EBV) latent infection meeting the following criteria: * The presence of EBV within the malignant cells has been demonstrated by immunohistochemistry for viral antigens or by EBER (EBV early RNA) in situ hybridization * Patients in remission from disease or with disease for which no standard treatment is appropriate, as defined by 1 of the following groups: * Have achieved a continuing complete response (CR) or unconfirmed CR * Residual masses at the site of treated disease that are not progressing (i.e., stable disease) and for which no standard therapy is recognized * Residual or recurrent disease that is low-volume and causing minimal or no symptoms and for which no standard therapy is recognized * Completed standard therapy for malignancy ≥ 12 weeks before trial entry * No more than 1 course of chemotherapy as treatment for EBV+ malignancy * No ongoing toxic manifestations of prior treatment, except alopecia or certain grade 1 toxicities at the discretion of the investigator and Cancer Research UK * No patients with active EBV+ cancer for whom evidence-based active treatment is available and likely to be offered to prolong life or relieve symptoms within 14 weeks of the first vaccination PATIENT CHARACTERISTICS: * WHO performance status 0 or 1 * Life expectancy ≥ 4 months * Lymphocyte count must satisfy 1 of the following criteria: * Greater than lower limit of the reference range in the investigator site * Greater than or equal to 0.5 x 10\^9/L AND recovery from nadir of lymphocyte numbers following primary treatment for EBV+ malignancy, judged by no successive rises in lymphocyte count measured up to 3 successive occasions 3 weeks apart * Hemoglobin \> 10.0 g/dL * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Serum alkaline phosphatase \< 1.5 times ULN * ALT and/or AST \< 1.5 times ULN * Calculated creatinine clearance \> 50 mL/min (uncorrected value) OR isotope clearance measurement \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during study and for 6 months after completion of study treatment * No known chronic active infection with hepatitis B, hepatitis C, or HIV * No history of anaphylaxis or severe allergy to vaccinations * No allergy to eggs or egg products * No ongoing active infection * No known splenic dysfunction * No concurrent active autoimmune disease * No prior NYHA class III or IV cardiac disease or concurrent congestive heart failure * No concurrent active skin diseases requiring therapy (i.e., psoriasis, eczema) * No other condition that, in the Investigator's opinion, would make the patient not a good candidate for this clinical trial PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior myeloablative therapy followed by an autologous or allogeneic hematopoietic stem cell transplant * More than 12 weeks since prior and no concurrent chemotherapy or radiotherapy * No splenectomy or splenic irradiation * No concurrent immunosuppressive medication, including corticosteroids * Long-term prophylactic use of inhaled corticosteroids allowed * No major thoracic and/or abdominal surgery within the past 4 weeks from which the patient has not yet recovered * No other concurrent anticancer or investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.