Clinical trial NCT01782508: A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma
Official title: A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Keywords: melanoma,adjuvant therapy,kit mutated melanoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: relapse free survival
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 18 months
Secondary outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 48 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: