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Health Condition(s) or Problem
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Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma
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Lay Summary
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The aim of NICAM is to see if a drug called nilotinib (Tasigna) is effective in the treatment of patients with a rare group of melanoma (acral (found on the palms of hands/soles of feet)) and mucosal (found inside body cavities rather than on the skin) that have a change (mutation) in a protein called c-KIT. Nilotinib interferes with the signalling insde cells with this mutation and it believed that this may lead to shrinkage of tumours. Tumour samples will be tested for the c-KIT mutation and the study will be offered to patiens with advanced acral or mucosal melanoma if the mutation is present (from UKCRN Portfolio)
Additional lay summaries...
http://www.cancerhelp.org.uk/trials/a-trial-looking-nilotinib-treat-acral-mucosal-melanoma-skin-cancer-spread (from ISRCTN)
The aim of this study is to see if a drug called nilotinib (Tasigna®) is effective in the
treatment of patients with a rare group of acral and mucosal melanomas that have a change
(mutation) in a protein called cKIT. Nilotinib interferes with signalling inside cells with
this mutation and it is believed that this may lead to shrinkage of tumours. Acral melanomas
are found on the palms and soles and mucosal melanomas start inside body cavities rather
than on the skin.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
1. Patients with c-KIT mutated histologically proven advanced mucosal or acral melanoma
in which the mutation is not known to be associated with nilotinib resistance.
2. Advanced mucosal and acral melanoma defined as unresectable locally advanced or
metastatic disease
3. The presence of one or more clinically or radiologically measurable lesions at least
10mm in size
4. Age 18 or greater
5. ECOG performance status 0, 1 or 2
6. Life expectancy greater than 12 weeks
7. At least 14 days since any major surgery
8. The capacity to understand the patient information sheet and ability to provide
written informed consent
9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures
10. Women must not be pregnant or lactating with no intention of pregnancy during study
treatment. Women of child bearing potential must have a negative serum pregnancy
test prior to study entry (even if surgically sterilised). Men and women of
childbearing potential must use adequate birth control measures (e.g. abstinence,
oral contraceptives, intrauterine device, barrier method with spermicide, implantable
or injectable contraceptives or surgical sterilisation) for the duration of the study
and should continue such precautions for 6 months after receiving the last study
treatment
11. Serum alanine transaminase (ALT) or serum aspartate aminotransferase =2.5 x upper
limit of normal (ULN) and total serum bilirubin =1.5 x ULN
12. Serum creatinine =1.5 x ULN
13. Serum lipase and amylase <1.5 x ULN
14. Haemoglobin =9.0 g/dL, absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L
15. Prothrombin time (PT) =1.5 x ULN
16. Able to swallow and retain oral medication.
Exclusion Criteria:
1. Intracranial disease, unless there has been radiological evidence of stable
intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence
of a disease-free interval of at least 3 months post surgery. All patients
previously treated for brain metastases must be stable off corticosteroid therapy for
at least 28 days
2. Women who are pregnant, nursing, or planning to become pregnant during the course of
the trial
3. Men who plan to father a child during the course of the trial
4. Use of any investigational drug within 30 days prior to screening (both cancer and
non cancer treatments)
5. Use of herbal or chinese medication
6. Use of therapeutic coumarin derivatives (ie warfarin, acenocoumarol, phenprocoumon)
7. Significant cardiac disease including patients who have or who are at significant
risk of developing prolongation of QTc
8. Severe and/or uncontrolled medical disease
9. Known chronic liver disease
10. Past medical history of chronic pancreatitis
11. Known HIV infection
12. Previous radiotherapy to 25% or more of the bone marrow
13. Radiation therapy in the 4 weeks prior to study entry
14. Prior exposure to a tyrosine kinase inhibitor
15. Known lactose intolerance
16. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's
disease or ulcerative colitis).
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Who cannot enter the trial
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Inclusion Criteria:
1. Patients with c-KIT mutated histologically proven advanced mucosal or acral melanoma
in which the mutation is not known to be associated with nilotinib resistance.
2. Advanced mucosal and acral melanoma defined as unresectable locally advanced or
metastatic disease
3. The presence of one or more clinically or radiologically measurable lesions at least
10mm in size
4. Age 18 or greater
5. ECOG performance status 0, 1 or 2
6. Life expectancy greater than 12 weeks
7. At least 14 days since any major surgery
8. The capacity to understand the patient information sheet and ability to provide
written informed consent
9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures
10. Women must not be pregnant or lactating with no intention of pregnancy during study
treatment. Women of child bearing potential must have a negative serum pregnancy
test prior to study entry (even if surgically sterilised). Men and women of
childbearing potential must use adequate birth control measures (e.g. abstinence,
oral contraceptives, intrauterine device, barrier method with spermicide, implantable
or injectable contraceptives or surgical sterilisation) for the duration of the study
and should continue such precautions for 6 months after receiving the last study
treatment
11. Serum alanine transaminase (ALT) or serum aspartate aminotransferase =2.5 x upper
limit of normal (ULN) and total serum bilirubin =1.5 x ULN
12. Serum creatinine =1.5 x ULN
13. Serum lipase and amylase <1.5 x ULN
14. Haemoglobin =9.0 g/dL, absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L
15. Prothrombin time (PT) =1.5 x ULN
16. Able to swallow and retain oral medication.
Exclusion Criteria:
1. Intracranial disease, unless there has been radiological evidence of stable
intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence
of a disease-free interval of at least 3 months post surgery. All patients
previously treated for brain metastases must be stable off corticosteroid therapy for
at least 28 days
2. Women who are pregnant, nursing, or planning to become pregnant during the course of
the trial
3. Men who plan to father a child during the course of the trial
4. Use of any investigational drug within 30 days prior to screening (both cancer and
non cancer treatments)
5. Use of herbal or chinese medication
6. Use of therapeutic coumarin derivatives (ie warfarin, acenocoumarol, phenprocoumon)
7. Significant cardiac disease including patients who have or who are at significant
risk of developing prolongation of QTc
8. Severe and/or uncontrolled medical disease
9. Known chronic liver disease
10. Past medical history of chronic pancreatitis
11. Known HIV infection
12. Previous radiotherapy to 25% or more of the bone marrow
13. Radiation therapy in the 4 weeks prior to study entry
14. Prior exposure to a tyrosine kinase inhibitor
15. Known lactose intolerance
16. Any malabsorption syndrome (i.e. partial gastrectomy, small bowel resection, Crohn's
disease or ulcerative colitis).
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What will happen
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Drug; nilotinib; nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment; nilotinib; Tasigna
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Primary aim
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Proportion of participants with the c-KIT mutation who remain progression free at 6 months.
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Secondary Aim
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toxicity of treatment; evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks); Yes; Treatment related toxicity will be assessed at each clinic visit approximately every 4 weeks whilst the patient continues on study treatment. Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).; response at 12 weeks; tumours measured at 12 weeks from start of treatment; No; Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST); overall survival; Expected to be 6 - 12 months (Measured from commencement of treatment until time of death); No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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