Immunotherapy of pediatric brain cancer
Phase 1
Recruiting
- Conditions
- neoplasm.Malignant Neoplasm of Temporal Lobe
- Registration Number
- IRCT2016080829257N1
- Lead Sponsor
- rmia University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Brain tumor without metastases or recurrence; glioma; meduloblastoma; CD4>350 cell/mm; 3-18 months = age =15 years; 10Kg =Weight; Confirmation of informed consent; Normal serum tests; Immunotherapy should be started at least 3 wks after last chemo or radiotherapy course
Exclusion criteria:
Cardiovascular-pulmnary diseases; Hepatitis B, C or HIV infections; tumor pressure on spinal cord; Patient who will need chemo or radiotherapy during immunotherapy; 470ms=Improved QT; ECG disorders; corticosteroides administration
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side effects. Timepoint: 72 hrs. Method of measurement: NCI COMMON TOXICITY CRITERIA.
- Secondary Outcome Measures
Name Time Method Clinical and Immunological Responses. Timepoint: At least one year. Method of measurement: Flow Cytometry, Elisa, Overal Survival, Progression Free Survival.