SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00991250|
Recruitment Status : Unknown
Verified February 2010 by SentoClone AB.
Recruitment status was: Recruiting
First Posted : October 7, 2009
Last Update Posted : February 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Biological: SentoClone® Drug: Temodal® or Dacarbazine Medac®||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
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.
SentoClone® are autologous tumour-reactive lymphocytes which 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. The lymphocytes are extracted from the collected lymph nodes and expanded in vitro, the lymphocytes are thereafter stimulated with tumour extract and returned to the patient intravenously as an autologous cell transfusion. The administered volume will be 100 ml for cell densities less than 3x106 cells/ml and 200 ml for cell densities of 3x106 cells/ml or more.
Active Comparator: Temodal® or Dacarbazine Medac®
To be decided by each centre as one of the following:
Drug: Temodal® or Dacarbazine Medac®
Dacarbazine (5-[3,3-Dimethyl-1-triazenyl]imidazole-4-carboxamide) is a widely used systemic treatment against advanced malignant melanoma. Dacarbazine is a cytostatic agent, which inhibits tumour growth by interfering with DNA-synthesises. The DNA-synthesis is inhibited by alkylation of the DNA molecule; however, it is unclear whether dacarbazine has other cytostatic impacts on cell mechanisms. Dacarbazine is inactive until liver passage, the liver converts dacarbazine to its reactive metabolites MTIC and HMMTIC, which alkylate DNA. Dacarbazine is light sensitive and needs to be administered intravenously.
A newer analogue to dacarbazine, temozolomide (Temodal®), has been developed for oral administration. Temodal® is administered in capsules and is rapidly absorbed reaching peak concentrations after 20 minutes. Temodal® is converted to MTIC at physiological pH, the same reactive molecule as dacarbazine is metabolized to in the liver.
- 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. [ Time Frame: At baseline and 18, 26 and 34 weeks after treatment ]
- Progression-free survival [ Time Frame: From baseline to week 34 after initiated treatment ]
- Overall survival [ Time Frame: From baseline to week 34 after initiated treatment ]
- Time to tumour progression [ Time Frame: From baseline to week 34 after initiated treatment ]
- Disease-free survival [ Time Frame: From baseline to week 34 after initiated treatment ]
- Time to treatment failure [ Time Frame: From baseline to week 34 after initiated treatment ]
- Duration of response [ Time Frame: From baseline to week 34 after initiated treatment ]
- Correlation between tumour response and tumour marker S100 [ Time Frame: From baseline to week 34 after initiated treatment ]
- Proportion of patients showing toxic symptoms according to CTCAE criteria [ Time Frame: From baseline to week 34 after initiated treatment ]
- Quality of life (EQ-5D and QLQ-C30) [ Time Frame: 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 [ Time Frame: From baseline to week 34 after initiated treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991250
|Lund, Skåne, Sweden, 22185|
|Contact: Christian Ingvar, MD +46 (0)46-17 10 00 firstname.lastname@example.org|
|Principal Investigator: Christian Ingvar, MD|
|Stockholm, Stockholms Län, Sweden, 11883|
|Contact: Peter Gillgren, MD +46 (0)8-616 23 84 email@example.com|
|Principal Investigator: Peter Gillgren, MD|
|Stockholm, Stockholms Län, Sweden, 17176|
|Contact: Johan Hansson, MD +46 (0)8-5177 36 40 firstname.lastname@example.org|
|Principal Investigator: Johan Hansson, MD|
|Umeå, Västerbottens Län, Sweden, 90185|
|Contact: Peter Naredi, MD +46 (0)90- 785 00 00 email@example.com|
|Principal Investigator: Peter Naredi, MD|
|Sahlgrenska Universitetssjukhuset||Not yet recruiting|
|Göteborg, Västra Götalands Län, Sweden, 41685|
|Contact: Jan E Mattsson, MD +46 (0)31-342 84 58 firstname.lastname@example.org|
|Principal Investigator: Jan E Mattsson, MD|
|Principal Investigator:||Christian Ingvar, MD||Lund University Hospital|