Clinical trial · Interventional
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
NCT00424515CI-TRIAL-00025078BUS255completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral/Lentiginous Melanoma | Acral Lentiginous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Chronically Sun Damaged Melanomas | — | UNRESOLVED | — |
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Imatinib
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Best Overall Response
- timeFrame
- 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).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDHodi 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. PMID 23775962
- DERIVEDZukotynski 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. PMID 25609545