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About
The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.
Full description
The MAT02 clinical trial is a phase 1 clinical trial with the objective to assess the safety, feasibility and immunological efficacy of the combined application of two immunological treatment modalities in patients with metastatic melanoma:
Enrollment
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Inclusion criteria
Exclusion criteria
Any of the above criteria are not met.
Significant history or current evidence of cardiovascular disease (e.g. uncontrolled congestive heart failure or hypertension, unstable coronary artery disease or serious arrhythmias) or major respiratory diseases. In questionable cases, a stress test should be performed.
Recipients of a major organ allograft. Autoimmune diseases such as, but not limited to, inflammatory bowel disease or multiple sclerosis. Vitiligo is not an exclusion criterion. Other serious chronic diseases.
Other serious illnesses, e.g. active infections requiring antibiotics, bleeding disorders.
Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen.
Patients diagnosed with prior malignancies (except adequately treated basal cell carcinomas of the skin or in situ carcinomas of the skin or in situ carcinomas of the cervix, surgically cured) within the past 5 years.
Patients with second advanced malignancies concurrently.
Active CNS metastases. (Note: Patients with brain metastases that have been completely resected at least one month prior to registration or have undergone gamma knife treatment with no evidence of recurrence on CT and who are neurologically stable, are not excluded).
Organic brain syndrome or significant psychiatric disorder which would preclude participation in the full protocol and follow-up.
Immunodeficiency, previous splenectomy or radiation therapy of the spleen.
Screening laboratory values:
a) Inadequate hematologic function defined by: i) White blood count (WBC) <3.0 x 109/l ii) Platelet count <100x109/l iii) Hemoglobin level <100 g/l b) Inadequate hepatic function as defined by either: i) Total bilirubin level >1.5 times the upper limit of normal (ULN) ii) Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN) c) Inadequate renal function defined as serum creatinine >1.5 times the ULN
Infectious diseases that can be transmitted via contact with blood, such as HIV, Hepatitis B and C.
Women who are pregnant or nursing will be excluded because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Central trial contact
Rolf Kiessling, MD, PhD; Maria Wolodarski, MD
Data sourced from clinicaltrials.gov
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