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MVX-ONCO-1 in Patients With Solid Tumor
Conditions
Solid Tumor - Cancer
Conditions: Keywords
cancer, solid tumors, gene therapy, cell therapy, encapsulation
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Treatment
Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Hopitaux Universitaires de Genève - HUG
Geneva, Genève, Switzerland
Status: Recruiting
Contact: Denis MIGLIORINI, MD - +41 22 372 29 01 - denis.migliorini@hcuge.ch
Start Date
March 2014
Completion Date
May 2019
Sponsors
Maxivax SA
Source
Maxivax SA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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