Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
Condition: Mucosal Melanoma; Acral/Lentiginous Melanoma; Chronically Sun Damaged Melanomas
MeSH terms: Melanoma
Intervention: Imatinib
Intervention description: Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imatinib; Gleevec

Summary:

      The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating
      acral/lentiginous and mucosal melanoma which has spread to other parts of the body in
      patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It
      is believed that imatinib may be effective in blocking signals on certain cancer cells which
      allow the malignant cells to multiply and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Melanomas that arise on chronically sun damaged skin and have pathologic evidence of
             solar elastosis

          -  History of primary mucosal or acral/lentiginous melanoma

          -  Histologically documented stage IV metastatic melanoma

          -  ECOG performance status 0,1, or 2

          -  Estimated life expectancy of 6 months or greater

          -  Age 18 years or older

          -  Creatinine < 1.5 x ULN

          -  ANC > 1500 ul

          -  Platelets > 100,000 ul

          -  Total bilirubin, AST, and ALT < 2 x ULN

          -  Amylase and lipase < 1.5 x ULN

          -  C-kit mutation documented from either primary or metastatic tumor site

          -  > 4 weeks from prior chemotherapy or investigational drug

          -  At least one measurable site of disease as defined by at least 1 cm in greatest
             dimension

        Exclusion Criteria:

          -  Severe and/or uncontrolled medical disease

          -  Pregnant or nursing mothers

          -  Any other significant medical, surgical, or psychiatric condition that my interfere
             with compliance

          -  Patient is < 5 years free of another primary malignancy except: basal cell skin cancer
             or a cervical carcinoma in situ

          -  Concurrent treatment with Warfarin

          -  Prior treatment with c-kit inhibitor

          -  Patient with Grade III/IV cardiac problems as defined by NYHA criteria

          -  No H2 blockers or proton pump inhibitors

          -  Known brain metastasis

          -  Known chronic liver disease

          -  Known diagnosis of HIV infection

          -  Previous radiotherapy to > 25% of the bone marrow

          -  Major surgery within 2 weeks prior to study entry

          -  Patient has received any other investigational agent within 28 days of first study
             drug dosing

          -  Chemotherapy within 4 weeks prior to study entry