melanoma skin cancer
Conditions
Interventions
A metastatic lesion will be removed and used to establish an autologous tumor
cell line that will be used to culture tumor-reactive T cells as well as for
preparation of the autologous tumor cell va
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Histologically proven melanoma. 3. Melanoma must be at one of the following AJCC 2009 stages: -Irresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification irresectable stage III melanoma, or -Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a, M1b or M1c), and normal LDH. 4. Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone. 5. Presence of measurable progressive disease according to RECIST version 1.1. 6. Expected survival of at least 3 months. 7. WHO performance status = 6,0 mmol/l Granulocytes >= 1,500/µl Lymphocytes >= 700/µl Platelets >= 100,000/µl Creatinine clearance >= 60 min/ml Serum bilirubin
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons:;1. Patients with brain metastases who are neurologically unstable and/or on use of dexamethasone. 2. Clinically significant heart disease (NYHA Class III or IV). 3. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study. 4. Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion. 5. Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma. 6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 7. Lack of availability for follow-up assessments. 8. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this phase I/II clinical trial is to demonstrate the feasibility and to evaluate the safety and toxicity of ACT plus vaccination according to CTCAE 4.0 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is the evaluation of a clinical response according to RECIST 1.1 and overall survival (OS). Clinical benefit is defined as Stable Disease (SD), Partial Response (PR), or Complete response (CR). An additional endpoint is to determine the induced immune response in patient*s blood and serum and in the T cells used for infusion. | — |
Countries
Netherlands
Outcome results
None listed