A Trial Looking at Nilotinib to Treat Acral and Mucosal Melanoma Skin Cancer That Has Spread (NICAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Institute of Cancer Research, United Kingdom.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01395121
First received: April 13, 2011
Last updated: May 18, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Mucosal Lentiginous Melanoma
Acral Lentiginous Malignant Melanoma
Drug: nilotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Nilotinib in the Treatment of Patients With c-KIT Mutated Advanced Acral and Mucosal Melanoma

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • Proportion of participants with the c-KIT mutation who remain progression free at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Progression free survival times will be measured from the date of enrolment into the treatment phase until the first date (following start of treatment) of either death or confirmed progressive disease according to RECIST.


Secondary Outcome Measures:
  • toxicity of treatment [ Time Frame: evaluated every 4 weeks whilst the patient is on treatment (on average estimated to be between 4 and 52 weeks) ] [ Designated as safety issue: 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 Study treatment will continue until the patient relapses or is withdrawn from study therapy (on average estimated to be between 4 and 52 weeks).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 [ Time Frame: tumours measured at 12 weeks from start of treatment ] [ Designated as safety issue: No ]
    Lesions must be measured and or evaluated at 12 weeks in accordance with the Response evaluation criteria in solid tumours (RECIST)

  • overall survival [ Time Frame: Expected to be 6 - 12 months (Measured from commencement of treatment until time of death) ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2009
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib
nilotinib 400mgs oral tablets
Drug: nilotinib
nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment
Other Name: Tasigna

Detailed Description:

NICAM has a two step consent process. Patients diagnosed with advanced acral or mucosal melanoma first consent for study registration and undergo screening tests including testing samples of melanoma tissue for the c-KIT mutation.

Following confirmation of the c-KIT mutation, patients are asked to consent to study entry with continuation of screening. Eligible patients then enter the study and commence taking nilotinib tablets twice a day for as long as clinical benefit is maintained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395121

Contacts
Contact: Gill Coombes +44 (0)2087224039 nicam-icrctsu@icr.ac.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: James Larkin, MA BM BCh MRCP PhD Royal Marsden NHS Foundation
  More Information

No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01395121     History of Changes
Other Study ID Numbers: ICR-CTSU/2009/10020, 2009-012945-49, Oxfordshire C 09/H0606/103, CRUK/09/028, CTA 15983/0226/001, ISRCTN 39058880
Study First Received: April 13, 2011
Last Updated: May 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Institute of Cancer Research, United Kingdom:
c-KIT mutation
advanced disease
tyrosine kinase inhibitors

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 29, 2014