Malignant melanoma stage III/IV Cancer Malignant melanoma of skin
Conditions
Interventions
Patients will receive RAB38/NY-MEL-1 peptide 400 µg mixed with 0.5 mL of Montanide® ISA-51 by intradermal injections, every 3 weeks (weeks 1, 4, 7, 10, 13 and 16) for six doses. Patients without disea
Sponsors
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic, measurable malignant melanoma stage III/IV who have declined, failed or completed standard therapy 2. Tumour expression of RAB38/NY-MEL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR) analysis 3. HLA-A2 positive 4. Expected survival of at least six months 5. Karnofsky performance scale greater than or equal to 60% 6. Full recovery from surgery 7. Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified: 7.1. Absolute neutrophil count (ANC) greater than or equal to 1000/mm^3 7.2. Platelets greater than or equal to 80.000/mm^3 7.3. Creatinine less than or equal to 1.5 mg/L 7.4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin all less than 2.5 x upper limit of normal (ULN) 8. Age greater than or equal to 18 years 9. Able and willing to give valid written inform consent 10. Both genders will be included
Exclusion criteria
Exclusion criteria: 1. Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) 2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders 3. Patients with serious intercurrent illness, requiring hospitalisation 4. Patients taking immunosuppressive drugs such as systemic corticosteroids. Topical or inhalational steroids are permitted. 5. Known human immunodeficiency virus (HIV) positivity 6. Other active malignancy within 1 year prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ 7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study 8. Lack of availability for immunological and clinical follow-up assessments 9. Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to enrolment 10. Pregnancy or breastfeeding 11. Women of childbearing potential: refusal or inability to use effective means of contraception 12. History of severe allergic reactions to vaccines or unknown allergens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Toxicities and adverse events (AE) defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 2. RAB38/NY-MEL-1 specific cellular and humoral immune responses (CD8 T cell responses, serum antibody responses) Measured at baseline, week 1, 4, 7, 10, 13, 16 and 19. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumour response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), measured at week 19. | — |
Countries
Germany
Outcome results
None listed