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MVX-ONCO-1 in Patients With Solid Tumor

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ClinicalTrials.gov Identifier: NCT02193503
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maxivax SA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Cancer Other: Treatment Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment
MVX-1-loaded capsules and injection of irradiated autologous tumor cells
 Other: Treatment
Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
Other Names:
  • - capsules MVX-1-loaded (medical device)
  • - irradiated autologous tumor cells (cell therapy)


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with Adverse Events and/or Serious Adverse Events [ Time Frame: 18 weeks ]
    Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.


Secondary Outcome Measures :
  1. Delayed type hypersensitivity reactions, Induction of a specific CD8 response [ Time Frame: 18 weeks ]
    immune monitoring

  2. imaging and metabolic monitoring [ Time Frame: 18 weeks ]
  3. tumor size [ Time Frame: 18 weeks ]
    document of tumor number, sites, size of lesions

  4. tumor pain [ Time Frame: 18 weeks ]
    intensity, site, frequency of pain, use of analgesics


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193503


Locations
Switzerland
Hopitaux Universitaires de Genève - HUG Recruiting
Geneva, Genève, Switzerland, 1205
Contact: Anna Patrikidou, MD    +41 22 372 29 01    anna.patrikidou@hcuge.ch   
Principal Investigator: Anna Patrikidou, MD         
Sponsors and Collaborators
Maxivax SA
Investigators
Principal Investigator: Anna Patrikidou, MD HUG
More Information
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Responsible Party: Maxivax SA
ClinicalTrials.gov Identifier: NCT02193503     History of Changes
Other Study ID Numbers: MVX-2011-01
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by Maxivax SA:
cancer
solid tumors
gene therapy
cell therapy
encapsulation