Surgically incurable stage III or IV malignant melanoma. MedDRA version: 9.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III MedDRA version: 9.1 Level: LLT Classification code 10025671 Term: Malignant melanoma stage IV
Conditions
Interventions
Product Name: SentoClone®
Pharmaceutical Form: Intravenous infusion
Trade Name: Dacarbazine Medac
Pharmaceutical Form: Intravenous infusion
Trade Name: Temodal
Pharmaceutical Form: Capsule, hard
Sponsors
SentoClone AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this study, the patients must fulfil all of the following criteria: 1. Surgically incurable stage III or IV malignant melanoma 2. At least one measurable lesion 3. WHO performance status 0-1 4. Life expectancy > 3 months 5. Diagnosed metastasis 6. One tumour draining lymph node surgically accessible 7. Measurable tumour manifestation after the harvest of tumour tissue and sentinel/metinel nodes* 8. Signed informed consent *Should be fulfilled after surgery (visit 2) for patients randomised to SentoClone®. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this study the patients must not meet any of the following criteria: 1. Known allergy against used trace substance patent blue and/or albumin technetium (Nanocoll) 2. Known allergy against gentamicin and/or phenol red 3. Any condition (medical, social, psychological or legal) that influences adequate information negatively or is considered to be a problem for the patient to cope with treatment and follow-up 4. Aplastic anaemia or myelofibrosis 5. Previous treatment with temozolomide or dacarbazine, or any other chemotherapy during the last 3 months 6. Disease progression following treatment with temozolomide or dacarbazine more than 3 months back 1 7. Previous radiotherapy of target lesion(s) or tumour draining lymph nodes which will be used for lymphocyte extraction 2 8. Ongoing systemic steroid treatment or other treatment influencing immune defence 9. History of other malignant tumour disease apart from adequately treated basalioma or squamous cell carcinoma of the skin more than 5 years ago 10. Positive test(s) for HIV and/or Hepatitis B and/or Hepatitis C and/or syphilis 11. Condition or disease which could influence the result of the study or which indicates that the patient runs risks by participating in this study 12. Participation in any other clinical study, involving other investigational methods or products that may influence the results of this trial, within 30 days prior to participating in this trial 1 Patients who responded on the treatment, terminated the treatment at least 3 months prior to the study, and later progressed do not fulfill exclusion criterion 6 2 Irradiated lesions are not considered to be measurable and are therefore not suitable as target lesions. Lesions which have been irradiated but shown progression are considered as measurable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To elucidate whether SentoClone® gives improved treatment responses in patients with advanced malignant melanoma in comparison to established reference treatment(s).;Secondary Objective: The secondary objectives in this study are: To compare SentoClone® with established reference treatment regarding progression-free survival, overall survival, time to tumour progression, disease-free survival, time to treatment failure, duration of response, correlation between tumour response and tumour markers, and QoL To compare the proportion of patients showing toxic symptoms in the respective treatment group To confirm the safety of SentoClone® ;Primary end point(s): Tumour response rate based on the evaluation of the Independent Endpoint Review Committee (IRC), defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using RECIST version 1.1 (Response Evaluation Criteria in Solid Tumours). | — |
Countries
Sweden
Outcome results
None listed