- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00424515
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)
October 16, 2016 updated by: F. Stephen Hodi, MD, Dana-Farber Cancer Institute
A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation.
Imatinib is a protein-kinase inhibitor.
It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
- To determine the time to progression.
Secondary
- To correlate c-kit mutational status with response to therapy.
- To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
- Tolerability of imatinib.
- To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
- To correlate c-kit amplification status with response to therapy.
Study Type
Interventional
Enrollment (Actual)
24
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 Locations
-
-
Colorado
-
Denver, Colorado, United States, 80045
- University of Colorado at Denver Health Sciences Center
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
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:
- Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
- History of primary mucosal or acral/lentiginous melanoma
- Histologically documented stage IV metastatic melanoma
- ECOG performance status 0,1, or 2
- Estimated life expectancy of 6 months or greater
- 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
- C-kit mutation documented from either primary or metastatic tumor site
- > 4 weeks from prior chemotherapy or investigational drug
- At least one measurable site of disease as defined by at least 1 cm in greatest dimension
Exclusion Criteria:
- Severe and/or uncontrolled medical disease
- Pregnant or nursing mothers
- Any other significant medical, surgical, or psychiatric condition that my 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 brain metastasis
- Known chronic liver disease
- Known diagnosis of HIV infection
- Previous radiotherapy to > 25% of the bone marrow
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
Imatinib
|
Imatinib was given at a dose of 400 mg orally daily (4 100mg pills).
Patients received treatment up to 12 months as long as they were receiving clinical benefit.
Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best Overall Response
Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
|
Best overall response (BOR) on treatment was based on RECIST 1.0 criteria.
For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
CR or PR confirmation required within 4 weeks.
Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions.
Stable disease (SD) is neither meeting PR or PD.
PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
CR is disappearance of all non-target lesions.
|
Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
|
Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study.
Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
|
Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).
|
Overall Survival
Time Frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).
|
Overall survival (OS) is defined as the time from study entry to death or date last known alive.
|
Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: F. Stephen Hodi, MD, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for melanomas harboring mutationally activated or amplified KIT arising on mucosal, acral, and chronically sun-damaged skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. doi: 10.1200/JCO.2012.47.7836. Epub 2013 Jun 17.
- Zukotynski K, Yap JT, Giobbie-Hurder A, Weber J, Gonzalez R, Gajewski TF, O'Day S, Kim K, Hodi FS, Van den Abbeele AD. Metabolic response by FDG-PET to imatinib correlates with exon 11 KIT mutation and predicts outcome in patients with mucosal melanoma. Cancer Imaging. 2014 Nov 12;14(1):30. doi: 10.1186/s40644-014-0030-0.
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
July 1, 2006
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 18, 2007
First Submitted That Met QC Criteria
January 18, 2007
First Posted (Estimate)
January 19, 2007
Study Record Updates
Last Update Posted (Estimate)
December 8, 2016
Last Update Submitted That Met QC Criteria
October 16, 2016
Last Verified
June 1, 2016
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
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- 06-056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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 Mucosal Melanoma
-
National Cancer Institute (NCI)RecruitingMucosal Melanoma | Anal Melanoma | Bladder Melanoma | Cervical Melanoma | Esophageal Melanoma | Gallbladder Melanoma | Mucosal Melanoma of the Head and Neck | Mucosal Melanoma of the Urinary System | Oral Cavity Mucosal Melanoma | Penile Mucosal Melanoma | Rectal Melanoma | Recurrent Mucosal Melanoma | Sinonasal... and other conditionsUnited States, Canada
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedMetastatic Melanoma | Stage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage III Mucosal Melanoma of the Head and Neck | Stage IVA Mucosal Melanoma of the Head and Neck | Stage IVB Mucosal Melanoma of the Head and Neck | Stage IVC Mucosal Melanoma...United States
-
Viewpoint Molecular TargetingMayo ClinicCompletedMelanoma (Skin) | Melanoma Stage IV | Melanoma, Uveal | Melanoma, MucosalUnited States
-
Viewpoint Molecular TargetingRecruitingMetastatic Melanoma | Melanoma (Skin) | Mucosal Melanoma | Melanoma Stage IV | Melanoma Stage III | Melanoma, UvealUnited States
-
Yonsei UniversityNot yet recruitingMucosal Melanoma | Acral MelanomaKorea, Republic of
-
Eye & ENT Hospital of Fudan UniversityCancer Institute and Hospital, Chinese Academy of Medical SciencesRecruitingMucosal Melanoma | Sinonasal MelanomaChina
-
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
-
Craig L Slingluff, JrUniversity of VirginiaCompletedMelanoma | Metastatic Melanoma | Mucosal MelanomaUnited States
-
Hoffmann-La RocheCompletedUveal Melanoma | Cutaneous Melanoma | Mucosal MelanomaSpain, United States, Belgium, Denmark, Canada, Australia
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Cutaneous Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Recurrent Mucosal Melanoma | Metastatic Mucosal Melanoma | Non-Cutaneous Melanoma | Metastatic Non-Cutaneous Melanoma | Recurrent Non-Cutaneous...United States, Canada, Ireland
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
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMelanoma | Skin NeoplasmsUnited States
-
Novartis PharmaceuticalsCompletedGastrointestinal Stromal TumorsUnited States, France, Belgium, Germany
-
University of Auckland, New ZealandLeukaemia & Blood Cancer New ZealandActive, not recruiting
-
Novartis PharmaceuticalsCompletedPulmonary Arterial HypertensionAustria, Germany, United States, United Kingdom