A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to compare the relapse free survival and overall survival of Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit mutation. It is assumed that Gleevec may be more effective on relapse free survival as the adjuvant treatment compared with Interferon.

Detailed Description
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If mutation tests show that the patient is eligible and they choose to participate in the study, they will be randomized and receive imatinib/Interferon. Each imatinib pill will be 100mg and the participants will take 4 pills once daily (400mg).Participants randomized to the interferon arm will receive Interferon 1500wiu/m2 d1-5 for 4 weeks followed by 900wiu IH TIW for 11 months. The following study procedures will also be performed at routine intervals throughout the course of treatment including blood tests, medical history updates, physical exams and Chest/Abdomen/Pelvic CT examinations.Participants will be on this study for one year and then be followed up to relapse or distal metastasis.

Official Title
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A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: imatinib
* Drug: Interferon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Melanoma patients whose primary tumor and regional lymphonodes (if have)have been resected Histologically documented AJCC stage IIB to IIIC C-kit mutation documented from either primary or metastatic lymphnode site ECOG performance status 0 or 1 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 no prior chemotherapy or investigational drug Exclusion Criteria: Severe and/or uncontrolled medical disease Pregnant or nursing mothers Any other significant medical, surgical, or psychiatric condition that may 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 chronic liver disease Known diagnosis of HIV infection 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinib<br>Participants will take 400mg tablets once daily for one year | Drug: imatinib<br>* a selectively inhibits the KIT protein tyrosine<br>* Other names: gleevec;|
| Active Comparator: inteferon<br>Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months | Drug: Interferon<br>* Interferon belongs to the large class of glycoproteins known as cytokines.<br>* Other names: Intron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse free survival |  | participants will be followed for the duration of hospital stay, an expected average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | From date of randomization until the date of death from any cause, assessed up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma,adjuvant therapy,kit mutated melanoma