Clinical trial · Interventional
A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma
A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
- 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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib | Drug | Imatinib | ALIAS |
| Interferon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- imatinib
- description
- Participants will take 400mg tablets once daily for one year
- interventionNames
- Drug: imatinib
- type
- ACTIVE_COMPARATOR
- label
- inteferon
- description
- Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months
- interventionNames
- Drug: Interferon
Primary outcomes (1)
- measure
- relapse free survival
- timeFrame
- participants will be followed for the duration of hospital stay, an expected average of 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available