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ISRCTN
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ISRCTN71711835
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ClinicalTrials.gov identifier
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Public title
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Pilot Phase III immunotherapy study in early breast cancer patients using oxidized mannan-MUC1
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Scientific title
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Acronym
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IFCM9
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Serial number at source
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EOF-27581
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Study hypothesis
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To evaluate patients with early/minimal residual disease of breast cancer after injection with oxidized mannan-MUC1.
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Lay summary
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Ethics approval
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Greek ethics committee approval 26 September 1997
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Study design
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A randomized double-blinded pilot study.
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Early breast cancer (Stage II)
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Participants - inclusion criteria
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1. Postmenopausal women (no menstrual period for >12 months)
2. Histological proven adenocarcinoma of the breast treated primarily by modified radical or partial mastectomy and axillary dissection followed by radiation of the residual breast
3. No more than 4 ipsilateral lymph nodes with metastases, not extending into the surrounding tissue and surgical margin free of disease
4. Tumor tissue with positive estrogen receptor
5. Tamoxifen 20 mg daily commencing within three months of breast surgery and to continue for 5 years
6. Adequate bone marrow function (white blood cells >4.0 x 10^9 per litre, haemogoblin >100 g per litre, platelets >100 x 10^9 per litre)
7. Adequate liver function (billirubin <60 mmol/litre i.e. < x 3 upper limit of normal)
8. Adequate renal function (creatinine <140 mmol/litre)
9. Life expectancy >12 weeks
10. Eastern Cooperative Oncology Group (ECOG) status between 0-2 (in bed <50% of daytime)
11. Written informed consent by the patient
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Participants - exclusion criteria
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1. Known metastatic breast cancer
2. Radiotherapy, chemotherapy, immunotherapy or investigation therapy within the last 4 weeks
3. Previous splenectomy or radiotherapy to spleen
4. Coexisting or previous other malignancies except in situ carcinoma of the cervix or basal cell carcinoma of the skin
5. Active uncontrolled infection
6. Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study
7. Concurrent systematic corticosteroid treatment
8. Autoimmune disease i.e. rheumatoid arthritis, systematic lupus erythematosus, except autoimmune thyroiditis
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Anticipated start date
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13/12/1997
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Anticipated end date
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18/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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31
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Interventions
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Injection with oxidized mannan-MUC1 versus placebo. This trial tests whether this method of injecting and the stage of the patient receiving vaccine is beneficial in patients against recurrence of breast cancer.
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Primary outcome measure(s)
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After more than 5.5 years from last patient start (8 years from first patient treatment), the recurrence rate in patients receiving the placebo was 4/15 (the expected rate of recurrence in Stage II breast cancer); those receiving immunotherapy had no recurrences (0/16) – a statistically significant result (p = 0.0292). Of the patients receiving oxidized mannan MUC1, 9/13 had measurable antibodies to MUC1 and 4/10 had MUC1 specific T cell responses; none of the placebo treated patients showed an immune response to MUC1.
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Secondary outcome measure(s)
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The results suggest that in early breast cancer, MUC1 immunotherapy is beneficial, and that a larger Phase III study should be undertaken.
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Sources of funding
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The Austin Research Institute, Heidelberg VIC Australia and Prolipsis Medical Center, Athens Greece.
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/pubmed/16776849
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Contact name
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Prof
Vasso
Apostolopoulos
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Address
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The Austin Research Institute
Studley Road
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City/town
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Heidelberg
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Zip/Postcode
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3084
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Country
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Australia
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Tel
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+61 (0)392870666
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Fax
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+61 (0)392870600
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Email
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v.apostolopoulos@ari.unimelb.edu.au
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Sponsor
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Prolipsis Medical Center (Greece)
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Address
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Sevastias 3 Street
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City/town
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Athens
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Zip/Postcode
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11528
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Country
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Greece
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Tel
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+30 (0)210 7483110
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Fax
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+30 (0)210 7483189
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Email
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helaca@hol.gr
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Date applied
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17/03/2006
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Last edited
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08/05/2008
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Date ISRCTN assigned
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24/03/2006
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