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A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma

Phase 2
Open (Enrolling)
Malignant Melanoma

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Trial Information

A Multi-centre, Two-arm, Randomized, Open, Phase II Study Investigating SentoClone® Compared to Reference Treatment in Advanced Malignant Melanoma

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.

Inclusion Criteria

Inclusion Criteria

To be eligible for inclusion in this study, the patients must fulfil all of the following

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(1)

8. Signed informed consent

(1) Should be fulfilled after surgery (visit 2) for patients randomised to SentoClone®.

Exclusion Criteria

To be eligible for inclusion in this study the patients must not meet any of the following

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

At baseline and 18, 26 and 34 weeks after treatment

Safety Issue:


Principal Investigator

Christian Ingvar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lund University Hospital


Sweden: Medical Products Agency

Study ID:

Mel-Swe-01 2009-12-17



Start Date:

October 2009

Completion Date:

September 2011

Related Keywords:

  • Malignant Melanoma
  • Malignant melanoma
  • Melanoma