Cancer, Solid Tumor
Conditions
Keywords
cancer, solid tumors, gene therapy, cell therapy, encapsulation
Brief summary
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.
Detailed description
Endpoints: Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.
Interventions
OTHERTreatment
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Sponsors
Maxivax SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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. * Therapeutic anticoagulation with coumarine or continues 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Adverse Events and/or Serious Adverse Events | 18 weeks | Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed type hypersensitivity reactions, Induction of a specific CD8 response | 18 weeks | immune monitoring |
| imaging and metabolic monitoring | 18 weeks | — |
| tumor size | 18 weeks | document of tumor number, sites, size of lesions |
| tumor pain | 18 weeks | intensity, site, frequency of pain, use of analgesics |
Countries
Switzerland
Outcome results
None listed