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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782508
• Other study ID #: AMN107A2301
• Status: Recruiting
• Phase: Phase 2
• First received: August 15, 2012
• Last updated: January 31, 2013
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Beijing Cancer Hospital
• Contact: Lu Si, MD
• Phone: +86(10)88196951
• Email: silu.net[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• imatinib
a selectively inhibits the KIT protein tyrosine
• Interferon
Interferon belongs to the large class of glycoproteins known as cytokines.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse free survival		participants will be followed for the duration of hospital stay, an expected average of 18 months	No
Secondary	overall survival		From date of randomization until the date of death from any cause, assessed up to 48 months	No