Malignant MelanomaPhase 2NCT00991250
SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
A Phase 2 study testing SentoClone® and Temodal® or Dacarbazine Medac® in people with Malignant Melanoma, run by SentoClone AB at 5 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- SentoClone® and Temodal® or Dacarbazine Medac®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesSweden
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for inclusion in this study, the patients must fulfil all of the following criteria:
- Surgically incurable stage III or IV malignant melanoma
- At least one measurable lesion
- WHO performance status 0-1
- Life expectancy > 3 months
- Diagnosed metastasis
Show all 10Show fewer
- One tumour draining lymph node surgically accessible
- Measurable tumour manifestation after the harvest of tumour tissue and sentinel/metinel nodes(1)
- Signed informed consent
- Should be fulfilled after surgery (visit 2) for patients randomised to SentoClone®.
Who cannot join
- 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
- 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
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Not yet recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, 41685
Jan E Mattsson, MD, +46 (0)31-342 84 58, jan.e.mattsson@vgregion.se
Jan E Mattsson, MD
- Recruiting
Lunds Universitetssjukhus
Lund, Skåne County, 22185
Christian Ingvar, MD, +46 (0)46-17 10 00, christian.ingvar@skane.se
Christian Ingvar, MD
- Recruiting
Södersjukhuset
Stockholm, Stockholm County, 11883
Peter Gillgren, MD, +46 (0)8-616 23 84, peter.gillgren@sodersjukhuset.se
Peter Gillgren, MD
- Recruiting
Karolinska Sjukhuset
Stockholm, Stockholm County, 17176
Johan Hansson, MD, +46 (0)8-5177 36 40, johan.hansson@karolinska.se
Johan Hansson, MD
- Recruiting
Norrlands Universitetssjukhus
Umeå, Västerbotten County, 90185
Peter Naredi, MD, +46 (0)90- 785 00 00, peter.naredi@surgery.umu.se
Peter Naredi, MD
About this study
Official title: A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
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).
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- SentoClone®, Temodal® or Dacarbazine Medac®
- Keywords
- Malignant melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentoClone®Biological
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.
Temodal® or Dacarbazine Medac®Drug
Also called DTIC, Dacarbazine, Temozolomide
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.
| Study group | Role | What they receive |
|---|---|---|
| SentoClone® | Experimental | 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. Receives: Biological: SentoClone® |
| Temodal® or Dacarbazine Medac® | Active comparator | 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. Receives: Drug: Temodal® or Dacarbazine Medac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 18, 26 and 34 weeks after treatment
Secondary outcomes (10)
Progression-free survival
Measured: From baseline to week 34 after initiated treatment
Overall survival
Measured: From baseline to week 34 after initiated treatment
Time to tumour progression
Measured: From baseline to week 34 after initiated treatment
Disease-free survival
Measured: From baseline to week 34 after initiated treatment
Time to treatment failure
Measured: From baseline to week 34 after initiated treatment
Duration of response
Measured: From baseline to week 34 after initiated treatment
Correlation between tumour response and tumour marker S100
Measured: From baseline to week 34 after initiated treatment
Proportion of patients showing toxic symptoms according to CTCAE criteria
Measured: From baseline to week 34 after initiated treatment
Quality of life (EQ-5D and QLQ-C30)
Measured: 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
Measured: From baseline to week 34 after initiated treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SentoClone AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Ingvar, MD, Principal investigator, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991250
- Sponsor's protocol ID
- Mel-Swe-01 2009-12-17
- Other IDs
- EudraCT No: 2008-007515-33
- Status last verified
- Feb 2010
- First submitted
- 5 Oct 2009
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00991250
- Acronym / sponsor ID
- Mel-Swe-01 2009-12-17
- Conditions
- Malignant Melanoma
- Keywords
- Malignant melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- SentoClone ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SentoClone® | Experimental | Biological: 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. |
| Temodal® or Dacarbazine Medac® | Active comparator | Drug: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- To be eligible for inclusion in this study, the patients must fulfil all of the following criteria:
- Surgically incurable stage III or IV malignant melanoma
- At least one measurable lesion
- WHO performance status 0-1
- Life expectancy > 3 months
Key exclusion criteria (4 listed)
- 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
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SentoClone®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. | Biological | SentoClone® |
| Temodal® or Dacarbazine Medac®Also: DTIC, Dacarbazine, TemozolomideDacarbazine (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. | Drug | Temodal® or Dacarbazine Medac® |
Primary outcome
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Ingvar, MD principal investigator
Lund University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SentoClone® and Temodal® or Dacarbazine Medac® in people with Malignant Melanoma, run by SentoClone AB at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2010.