MVX-ONCO-1 in Patients With Solid Tumor

Trial Title: MVX-ONCO-1 in Patients With Solid Tumor

NCT ID: NCT02193503

Condition: Solid Tumor
Cancer

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
cancer
solid tumors
gene therapy
cell therapy
encapsulation

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Treatment
Description: Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Arm group label: treatment

Other name: - capsules MVX-1-loaded (medical device)

Other name: - irradiated autologous tumor cells (cell therapy)

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hopitaux Universitaires de Genève - HUG

Address:
City: Geneva
Zip: 1205
Country: Switzerland

Start date: March 2014

Completion date: December 2026

Lead sponsor:
Agency: Maxivax SA
Agency class: Industry

Source: Maxivax SA

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02193503