SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
- Conditions
- Malignant Melanoma
- Interventions
- Biological: SentoClone®
- Registration Number
- NCT00991250
- Lead Sponsor
- SentoClone AB
- Brief Summary
The purpose of this study is to elucidate whether SentoClone® gives improved treatment responses in patients with advanced malignant melanoma in comparison to established reference treatment(s).
- Detailed Description
Malignant melanoma is one of the most common cancer forms worldwide and WHO estimates 132,000 new cases each year. The incidence rate vary up to 150-fold between different regions and ethnicities, the highest rates are found in emigrated Caucasian populations (e.g. Australia and New Zealand).
There are few therapy alternatives for advanced malignant melanomas. At present, dacarbazine (Dacarbazine Medac®) is the most commonly used therapy. Immunotherapy with IL-2 and IFN is an alternative, but it is associated with multiple side effects. Hence, there remains a considerable need for alternative treatments.
By using SentoClone®, autologous tumour-reactive lymphocytes are expanded and infused to the patient, where they have the opportunity to seek out and attack the primary tumour and metastases. The first step is to identify the tumour draining lymph node(s), which is done in parallel to surgical resection of the primary tumour or metastasis. The sentinel and/or metinel node(s), the initial meeting place between tumour antigen and the immune system, are further dissected and collected during the surgery.
In this study SentoClone® will be compared with Dacarbazine Medac® and Temodal® which are currently regarded as standard first-line therapies in advanced malignant melanoma.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Temodal® or Dacarbazine Medac® Temodal® or Dacarbazine Medac® To be decided by each centre as one of the following: 1. Temodal® (temozolomide) 2. Dacarbazine Medac® (dacarbazine) The reference treatment regimen should follow the general guiding principles for each of the two reference treatments. SentoClone® SentoClone® SentoClone®: Specific tumour-reactive lymphocytes located in lymph nodes directly draining primary tumours or metastases are identified and expanded. These lymphocytes are infused to the patient to treat metastatic disease.
- Primary Outcome Measures
Name Time Method Tumour response rate, defined as complete response (CR) or partial response (PR) (i.e. at least partial response) measured using the RECIST (Response Evaluation Criteria in Solid Tumours) criteria. At baseline and 18, 26 and 34 weeks after treatment
- Secondary Outcome Measures
Name Time Method Time to treatment failure From baseline to week 34 after initiated treatment Progression-free survival From baseline to week 34 after initiated treatment Overall survival From baseline to week 34 after initiated treatment Time to tumour progression From baseline to week 34 after initiated treatment Disease-free survival From baseline to week 34 after initiated treatment Duration of response From baseline to week 34 after initiated treatment Correlation between tumour response and tumour marker S100 From baseline to week 34 after initiated treatment Proportion of patients showing toxic symptoms according to CTCAE criteria From baseline to week 34 after initiated treatment Quality of life (EQ-5D and QLQ-C30) From baseline to week 34 after initiated treatment Adverse Events (AEs) classified according to seriousness, causality, and intensity, clinically significant deviations in vital signs, clinical chemistry, and haematology From baseline to week 34 after initiated treatment
Trial Locations
- Locations (5)
Norrlands Universitetssjukhus
🇸🇪Umeå, Västerbottens Län, Sweden
Karolinska Sjukhuset
🇸🇪Stockholm, Stockholms Län, Sweden
Lunds Universitetssjukhus
🇸🇪Lund, Skåne, Sweden
Södersjukhuset
🇸🇪Stockholm, Stockholms Län, Sweden
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Västra Götalands Län, Sweden