RPCEC00000224RecruitingPhase 1
Active specific immunotherapy with the vaccine preparation NGcGM3 / VSSP in patients with small cell lung cancer
Center of Molecular Immunology (CIM)0 sites40 target enrollmentStarted: December 7, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to one (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with measurable lesions by application of RECIST version 1.1.
- •2.Patients older than 18 years.
- •3.Patients who consent to participate in the study by signing the informed consent model.
- •4.Patients with ECOG scale of Performance Status = 2.
- •5.Patients with normal functioning of organs and bone marrow defined by laboratory parameters.
Exclusion Criteria
- •1.Patients who have been treated with NGcGm3 / VSSP within 6 months prior to recruited.
- •2.Patients who have been included in another clinical trial within 6 months prior to recruited.
- •3.Patients who are pregnant or breastfeeding.
- •4.Patients with brain metastases.
- •5.Patients with acute or chronic infectious diseases.
- •6.Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the vaccine.
- •7.Patients with autoimmune diseases.
- •8.Patients with descompensated chronic diseases.
Investigators
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