AN OPEN PHASE I CLINICAL STUDY ASSESSING SAFETY AND TOLERABILITY OF MVX-ONCO-1 IN PATIENTS WITH SOLID TUMOR WHO ARE NOT/NOT ANY LONGER AMENABLE TO STANDARD THERAPY “Etude MaxiVax” Sponsor: MaxiVAX S.A. CONTACTS AUX HUG : Unité de recherche en Onco-Hématologie de la Fondation DFDL Coordinatrice de l’étude : Mme Virginie Ancrenaz-Sirot 079 55 32 381 Investigateur responsable: Dr Denis Migliorini, 079 55 34 417 Secrétariat: Mme Florence Marti-Klay, 022 372 29 01 DESIGN DE L’ETUDE 15 patients souffrant de tumeurs solides pour lesquels les traitements reconnus et disponibles ne sont plus efficaces ou pas utilisables seront inclus aux HUG. Le traitement qui sera administré pendant l’étude est appelé "immunothérapie cellulaire spécifique MVX-ONCO". Le traitement sera répété toutes les semaines pendant 4 semaines puis 2 implantations supplémentaires à 15 jours d’intervalle. Le nombre total d’implantations prévues est donc de 6 sur une durée totale de 8 semaines selon le tableau ci-dessous. Semaine Jours Retrait des capsules Immunisation Visites médicales Etude MaxiVax 1 J-1 I n°1 V-1 2 J-8 E n°1 I n°2 V-2 3 J-15 E n°2 I n°3 V-3 4 J-22 E n°3 I n°4 V-4 5 J-29 E n°4 V-5 dngn 02.06.2015 6 J-36 I n°5 V-6 7 J-43 E n°5 V-7 8 J-50 I n°6 V-8 9 J-57 E n°6 V-9 OBJECTF DE L’ETUDE L'objectif de cet essai clinique est d'évaluer la sécurité, la tolérance ainsi que la réponse immunitaire et clinique induite par le traitement MVX-ONCO. Durant l’étude diverses analyses seront effectuées pour évaluer ces paramètres (sécurité, tolérance, faisabilité, réponse immunitaire, réponse anti-tumorale). CRITERES D’INCLUSION / EXCLUSION # 1 2 3 4 5 6 7 9 10 11 # 1 2 3 4 5 6 7 8 9 10 11 INCLUSION CRITERIA Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment are exhausted or not feasible Life expectancy: estimate of at least 4 months Performance status grade 0-2 (WHO grading) No major impairment of liver function (ALT < 2.5 times the upper limit of normal range, Bilirubin within the normal range (exception: liver metastases: ALT < 5 times ULN; Bilirubin < 3 times UL) No major impairment of renal function (creatinine ≤ 1.5 times the upper limit of normal range) No major impairment of bone marrow function (hemoglobin > 9.0 g/dl, WBC >2.5 x 109/L, neutrophils≥1.5 x109L, Thrombocytes≥50 x109/L Primary tumor and/or metastasis amenable for partial/total surgery or tap and subsequent cell harvesting estimate > 27x106 cells Ability to understand the concept of a clinical trial Able to understand Patient Information Form and Inform Consent Form Has given written informed consent EXCLUSION CRITERIA Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks Have received any chemotherapy treatment in the 4 preceding weeks Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders. History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent. Patient with a systemic disease other than cancer, that is not controlled by usual medication Untreated brain metastasis (screening CT or MRI mandatory even for asymptomatic patients). Patient with history of brain metastasis with no evidence of brain relapse after surgery/radiotherapy at screening can be enrolled Is there uncontrolled bleeding Chronic immunosuppressive treatment including steroids > 30mg cortisone or equivalent/day Therapeutic anticoagulation with coumarine or continuous iv heparin. Low- molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm). Known allergy to reagents in the study product (MVX-ONCO-1) such as penicillin, streptomycin.). Etude MaxiVax dngn 02.06.2015