A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
relapse free survival
participants will be followed for the duration of hospital stay, an expected average of 18 months
Jun Guo, M.D.
Peking University Cancer Hospital
China: Food and Drug Administration