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Phase 1 Study of The Adoptive Immunotherapy for Solid Tumors Using Modified Autologous Cytokine-induced Killer Cells.


Phase 1/Phase 2
8 Years
60 Years
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

Phase 1 Study of The Adoptive Immunotherapy for Solid Tumors Using Modified Autologous Cytokine-induced Killer Cells.


Inclusion Criteria:



1. Patient must be at least 18 year-old, or allowance from their parent if younger than
that.

2. Patient must have histologically or cytologically confirmed advanced
Cholangiocarcinoma by oncologist

3. Cholangiocarcinoma have been failing to current treatment.

4. Patient is healthy by getting an Eastern Co-operative Oncology Group (ECOG)
performances status of 0, 1 or 2.

5. 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

6. 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

7. Patients will to comply and provide written informed consent prior to enrollment into
the study.

Exclusion Criteria:

1. Patients received chemotherapy within 4 weeks before study entry.

2. Active uncontrolled infection

3. Concurrent anti-cancer treatment in another investigational trial, including
immunotherapy in last 30 days

4. 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

5. Concurrent steroid therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MRI scan for monitoring of tumor size and CIK cell-homing, Fluorescence-activated cell sorting (FACS) analysis

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Authority:

Thailand:Siriraj Institutional Review Board

Study ID:

215-3-2552

NCT ID:

NCT01868490

Start Date:

April 2009

Completion Date:

May 2014

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma
  • Cytokine induced killer cells
  • CIK
  • Treg
  • Th17
  • Cholangiocarcinoma

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