Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2006-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MVA Vaccine
MVA Vaccine
The starting dose will be 5 x 107 plaque forming units (pfu) given by intradermal vaccination. Cohorts of three patients will receive escalating doses of the vaccine (100%, 100%, 67% and 50%). The dose escalation scheme is 5 x 107 pfu, 1 x 108 pfu, 2 x 108 pfu, 3.3 x 108 pfu, 5 x 108pfu. This will be dependant on toxicity.
Interventions
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MVA Vaccine
The starting dose will be 5 x 107 plaque forming units (pfu) given by intradermal vaccination. Cohorts of three patients will receive escalating doses of the vaccine (100%, 100%, 67% and 50%). The dose escalation scheme is 5 x 107 pfu, 1 x 108 pfu, 2 x 108 pfu, 3.3 x 108 pfu, 5 x 108pfu. This will be dependant on toxicity.
Eligibility Criteria
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Inclusion Criteria
* Patients in remission from disease, ie complete response (CR) or unconfirmed complete response (CRu).
* Completion of standard therapy for malignancy at least 12 weeks before trial entry.
* Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.
* Age greater than 18 years.
* World Health Organisation (WHO) performance status of 0 or 1
* Life expectancy of at least 4 months.
* Haematological and biochemical indices (these measurements must be performed within 28 days prior to the patient going on study):
* Haemoglobin (Hb) \> 10.0 g/dl
* Lymphocytes \> 1.0 x 109/L (or above the lower limit of normal range of institutional laboratory)
* Neutrophils ≥ 1.5 x 109/L
* Platelets (Plts) ≥ 100 x 109/L
* baseline liver function tests :
* Serum bilirubin ≤ 1.5 x upper normal limit
* Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) \< 1.5 x ULN.
* baseline renal function test:
* calculated creatinine clearance \> 50ml/min Female patients of child-bearing potential are eligible, provided they have a negative pregnancy test prior to enrolment and agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
* Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
Exclusion Criteria
* Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Current active autoimmune disease.
* Current active skin diseases requiring therapy (psoriasis, eczema etc).
* Ongoing active infection.
* History of anaphylaxis or severe allergy to vaccination.
* Allergy to eggs or egg products.
* Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant.
* Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction.
* Receiving current immunosuppressive medication, including corticosteroids.
* Pregnant and lactating women.
* Ongoing toxic manifestations of previous treatment. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
* Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
* Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
* Concurrent congestive heart failure or prior history of class III/ IV cardiac disease
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CCTU
Comprehensive Clinical Trial Unit
Principal Investigators
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Anthony TC Chan, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Oncology, The Chinese University of Hong Kong
Locations
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Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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VAC002
Identifier Type: -
Identifier Source: org_study_id