Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

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.

Inclusion Criteria:

- Melanoma patients whose primary tumor and regional lymphonodes (if have)have been

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

relapse free survival

Outcome Time Frame:

participants will be followed for the duration of hospital stay, an expected average of 18 months

Safety Issue:


Principal Investigator

Jun Guo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

December 2014

Related Keywords:

  • Melanoma
  • melanoma,adjuvant therapy,kit mutated melanoma
  • Melanoma