Status:
COMPLETED
Vaccine Therapy in Treating Patients With Epstein-Barr Virus-Related Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Gastric Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * To determine safety and to characterize the toxicity profile of EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine in patients in re...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01147991
Start Date
March 1 2005
End Date
April 1 2011
Last Update
February 28 2012
Active Locations (3)
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1
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
2
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
3
Christie Hospital
Manchester, England, United Kingdom, M20 4BX