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

Peking University Cancer Hospital & Institute

Status and phase: Unknown; Phase 2

Conditions: Melanoma

Treatments: Drug: imatinib; Drug: Interferon

Study type: Interventional

Funder types: Other

Identifiers

NCT01782508

AMN107A2301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

imatinib

Experimental group

Description:

Participants will take 400mg tablets once daily for one year

Treatment:

Drug: imatinib

inteferon

Active Comparator group

Description:

Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months

Treatment:

Drug: Interferon