- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782508
A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma
January 31, 2013 updated by: Lu Si, Peking University Cancer Hospital & Institute
A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lu Si, MD
- Phone Number: +86(10)88196951
- Email: silu.net@hotmail.com
Study Locations
-
-
-
Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Lu Si, MD
- Phone Number: +86(10)88196951
- Email: silu.net@hotmail.com
-
Sub-Investigator:
- Lu Si, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: imatinib
Participants will take 400mg tablets once daily for one year
|
a selectively inhibits the KIT protein tyrosine
Other Names:
|
Active Comparator: inteferon
Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months
|
Interferon belongs to the large class of glycoproteins known as cytokines.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
relapse free survival
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 18 months
|
participants will be followed for the duration of hospital stay, an expected average of 18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 48 months
|
From date of randomization until the date of death from any cause, assessed up to 48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jun Guo, M.D., Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
January 31, 2013
First Posted (Estimate)
February 4, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
January 31, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Interferons
- Imatinib Mesylate
Other Study ID Numbers
- AMN107A2301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
-
Viewpoint Molecular TargetingRecruitingMetastatic Melanoma | Melanoma (Skin) | Mucosal Melanoma | Melanoma Stage IV | Melanoma Stage III | Melanoma, UvealUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
Clinical Trials on imatinib
-
Centre Leon BerardCompletedGastrointestinal Stromal Tumors | Resected Gastrointestinal Stromal Tumors | Non-metastatic | High Risk of Recurrence | KIT Gene MutationFrance
-
Scandinavian Sarcoma GroupCompleted
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedChronic Myeloid LeukemiaChina
-
Sarit AssoulineNovartisRecruitingChronic Myeloid Leukemia | Chronic Myeloid Leukemia in Remission | Chronic Myeloid Leukemia, BCR/ABL-PositiveCanada
-
Seoul St. Mary's HospitalNovartisUnknownChronic Myeloid LeukemiaKorea, Republic of
-
M.D. Anderson Cancer CenterNovartisCompletedGastrointestinal Stromal TumorsUnited States
-
Novartis PharmaceuticalsCompletedGastrointestinal Stromal TumorsUnited States, France, Belgium, Germany
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMelanoma | Skin NeoplasmsUnited States
-
University of Auckland, New ZealandLeukaemia & Blood Cancer New ZealandActive, not recruiting
-
Novartis PharmaceuticalsCompletedPulmonary Arterial HypertensionAustria, Germany, United States, United Kingdom