Clinical trial NCT02193503: MVX-ONCO-1 in Patients With Solid Tumor
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Cancer
Keywords: cancer
solid tumors
gene therapy
cell therapy
encapsulation
Lead sponsor: Maxivax SA
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with Adverse Events and/or Serious Adverse Events
timeFrame: 18 weeks
Secondary outcomes:
measure: Delayed type hypersensitivity reactions, Induction of a specific CD8 response
timeFrame: 18 weeks
measure: imaging and metabolic monitoring
timeFrame: 18 weeks
measure: tumor size
timeFrame: 18 weeks
measure: tumor pain
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Genève - HUG
state: Genève
Study officials:
affiliation: HUG
name: Eugenio Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: