Overview

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

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Cancer Hospital
Treatments:
Imatinib Mesylate
Interferons
Criteria
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