Status:
COMPLETED
Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients. We evaluate the ability ...
Eligibility Criteria
Inclusion
- For arm A and B
- Histological documented evidence of colorectal cancer.
- Primary tumor surgically removed, recurrence(s) in the liver.
- Planned surgical excision of liver metastases.
- HLA-A2.1 phenotype according to lymphocyte HLA typing.
- Expression of CEA on primary tumor.
- ECOG performance status 0-1, life expectancy \> 3 months.
- Age 18-75 years.
- WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l.
- Expected adequacy of follow-up.
- Written informed consent.
Exclusion
- Clinical signs of extra hepatic metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.
- Prior chemotherapy, immunotherapy, or radiotherapy within three months before planned surgical excision is allowed.
- A history of myocardial infarction, angina pectoris, cardiac arrhythmias, cerebrovascular accidents, transient ischemic attacks or severe hypertension (exclusion criteria for autologous blood donation)
- Concomitant use of corticosteroids or other immunosuppressive agents.
- A history of any second malignancy in the past five years excluding adequately treated basal carcinoma of skin or carcinoma in situ of cervix.
- Serious concomitant disease, active infections. Specifically, patients with autoimmune disease or organ allografts and patients with a history of HBsAg or HIV are excluded.
- A known allergy to shell fish.
- Pregnant or lactating women.
- For arm C (side-study)
- inclusion criteria:
- histological proof of colorectal cancer
- HLA-A0201 positive
- stage III (T1-4N1-2M0) cancer or high risk stage II (T4 and/or poor differentiation in histology and/or perforation and/or obstruction and/or venous invasion and/or histological analysis of ≤10 lymph nodes)
- ≤ 8 weeks since surgical resection of primary colorectal tumor
- Age 18-75 years
- WHO performance 0-1 (Karnofsky 100-70%)
- WBC ≥ 3.0x109/l
- Platelets ≥ 100x109/l
- Hb ≥ 6 mmol/l
- Total bilirubin ≤ 2x UNL
- ASAT and ALAT ≤ 3x UNL
- Serum creatinine ≤ 1.5 x UNL
- Expected adequacy of follow-up
- Signed written informed consent
- exclusion criteria
- A history of second malignancy within the last 5 years. Adequately treated basal carcino¬ma of skin or carcinoma in situ of cervix is acceptable within this period
- Serious concomitant disease. Autoimmune disease or organ grafts.
- Other serious concomitant diseases preventing the safe administration of study drugs or likely to interfere with the study assessments.
- A known allergy to shell fish (contains KLH)
- Pregnant or lactating women
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00228189
Start Date
December 1 2003
End Date
November 1 2010
Last Update
November 30 2010
Active Locations (1)
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1
Radboud University Nijmegen Medical Center, dept. of Medical Oncology
Nijmegen, Netherlands, P.O. box 9101 6500 HB