Status:
COMPLETED
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Melanoma Stage III or IV
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, and both immunological a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically documented evidence of melanoma
- Stage III-IV melanoma according to the 2001 AJCC criteria
- Radical lymph node dissection planned, either with curative (stage III) or palliative (stage IV) intent
- Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
- HLA-A2.1 phenotype according to lymphocyte HLA typing
- ECOG performance status 0-1, life expectancy \> 3 months
- Age 18-75 years
- Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no residual toxicity of prior treatment.
- 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
- Written informed consent
- Expected adequacy of follow-up
- Exclusion criteria:
- No clinical signs of CNS metastases, in patients with a clinical suspicion of other metastases diagnostic tests should be performed to exclude this.
- No concomitant use of corticosteroids or other immunosuppressive agents
- No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period
- No serious concomitant disease, no active infections. No autoimmune disease or organ allografts, no clinical suspicion of HIV or Hepatitis B
- No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads, cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to shell fish (contains KLH)
- No pregnant or lactating women
Exclusion
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00243594
Start Date
September 1 1999
Last Update
February 19 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud University Nijmegen Medical Centre
Nijmegen, PO Box 9101, Netherlands, 6500 HB