Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
34 participants
INTERVENTIONAL
2014-03-31
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
MVX-1-loaded capsules and injection of irradiated autologous tumor cells
Treatment
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Interventions
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Treatment
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy: estimate of at least 4 months.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Maxivax SA
INDUSTRY
Responsible Party
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Principal Investigators
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Eugenio Fernandez, MD
Role: PRINCIPAL_INVESTIGATOR
HUG
Locations
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Hopitaux Universitaires de Genève - HUG
Geneva, Canton of Geneva, Switzerland
Countries
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Other Identifiers
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MVX-2011-01
Identifier Type: -
Identifier Source: org_study_id
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