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

Primary Purpose

Melanoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

imatinib

Interferon

About this trial

This is an interventional treatment trial for Melanoma focused on measuring melanoma,adjuvant therapy,kit mutated melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

imatinib

inteferon

Arm Description

Participants will take 400mg tablets once daily for one year

Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months

Outcomes

Primary Outcome Measures

relapse free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT01782508

First Posted

August 15, 2012

Last Updated

January 31, 2013

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT01782508

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

melanoma,adjuvant therapy,kit mutated melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

imatinib

Arm Type

Experimental

Arm Description

Participants will take 400mg tablets once daily for one year

Arm Title

inteferon

Arm Type

Active Comparator

Arm Description

Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months

Intervention Type

Drug

Intervention Name(s)

imatinib

Other Intervention Name(s)

gleevec

Intervention Description

a selectively inhibits the KIT protein tyrosine

Intervention Type

Drug

Intervention Name(s)

Interferon

Other Intervention Name(s)

Intron

Intervention Description

Interferon belongs to the large class of glycoproteins known as cytokines.

Primary Outcome Measure Information:

Title

relapse free survival

Time Frame

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

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

From date of randomization until the date of death from any cause, assessed up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Si, MD

Phone

+86(10)88196951

silu.net@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Guo, M.D.

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lu Si, MD

Phone

+86(10)88196951

silu.net@hotmail.com

First Name & Middle Initial & Last Name & Degree

Lu Si, MD

12. IPD Sharing Statement

Learn more about this trial

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

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