Lymphoma Clinical Trial
Official title:
A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Birmingham | Birmingham | England |
United Kingdom | Royal Marsden - London | London | England |
United Kingdom | Christie Hospital | Manchester | England |
Lead Sponsor | Collaborator |
---|---|
Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of drug-related grade 3 or 4 systemic or local adverse events (defined using the NCI CTCAE version 3.0) | Yes | ||
Primary | Occurrence of local skin reactions considered related to the vaccination | Yes | ||
Primary | Occurrence of drug-related systemic reactions (e.g., transient fever) | Yes | ||
Primary | 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 ... | No | ||
Secondary | Measurement of EBV-genome levels in plasma | No |
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