Status:
ENROLLING_BY_INVITATION
The Adoptive Immunotherapy for Solid Tumors Using Modified Autologous CIK Cells
Lead Sponsor:
Siriraj Hospital
Collaborating Sponsors:
Mahidol University
Conditions:
Cholangiocarcinoma
Neuroblastoma
Eligibility:
All Genders
8-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Cytokine-induced killer (CIK) cells exhibit high proliferation rate and cytotoxic activity in vitro. The major effector cells are the CD3+CD56+ subset. The cytolytic activity of CIK cells being indepe...
Eligibility Criteria
Inclusion
- Patient must be at least 8 year-old, or allowance from their parent if younger than that.
- Patient must have histologically or cytologically confirmed advanced cholangiocarcinoma or neuroblastoma by oncologist
- The cancers have been failing to current treatment.
- Patient is healthy by getting an Eastern Co-operative Oncology Group (ECOG) performances status of 0, 1 or 2.
- Any of the following lab data
- a. Hematology:
- Hb \> 8 g/dl
- Absolute neutrophil count (ANC) \> 1,500 cells/mm3
- Absolute lymphocyte count \> 1,000 cells/mm3
- Platelet \> 100x109/L
- Patient must have a life expectancy of at least 12 weeks by
- a. Biochemistry:
- Serum total bilirubin \< 3 mg/dl
- Serum creatinine \< 2 mg/dl
- Patients will comply and provide written informed consent prior to enrollment into the study.
Exclusion
- Patients received chemotherapy within 4 weeks before study entry.
- Active uncontrolled infection
- Concurrent anti-cancer treatment in another investigational trial, including immunotherapy in last 30 days
- Pregnant or lactating woman, or women of child bearing potential or less than one year after menopause (unless surgically sterile) with urine pregnancy test positive
- Concurrent steroid therapy
Key Trial Info
Start Date :
April 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01868490
Start Date
April 17 2009
End Date
May 30 2028
Last Update
February 10 2025
Active Locations (2)
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1
Siriraj Clinical Research Center, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
2
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700