Clinical trial · Interventional
Study of Temzolomide and Gleevec in Advanced Melanoma
Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma
NCT00667953CI-TRIAL-00065162terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty enrolling subjects
Summary
Brief summary (as posted)
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec | Drug | — | UNRESOLVED |
| Temodar | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A:
- description
- Temozolomide plus imatinib
- interventionNames
- Drug: Gleevec
- Drug: Temodar
Primary outcomes (1)
- measure
- Safety - Grade 3 or 4 Adverse Events
- timeFrame
- through study completion, an average of 1 year
- description
- Number of reported grade 3 or 4 adverse events
Secondary outcomes (2)
- measure
- Response
- timeFrame
- through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide * Measurable disease * Performance status \<= 2 * Life expectancy greater than 3 months Exclusion Criteria: * No prior treatment with temozolomide or imatinib mesylate * Organ allografts * Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area * Pregnancy or lactation * History of second cancer * Known hypersensitivity to temozolomide or imatinib * Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment
References
Publications (1)
- RESULTBajor DL, Xu X, Torigian DA, Mick R, Garcia LR, Richman LP, Desmarais C, Nathanson KL, Schuchter LM, Kalos M, Vonderheide RH. Immune activation and a 9-year ongoing complete remission following CD40 antibody therapy and metastasectomy in a patient with metastatic melanoma. Cancer Immunol Res. 2014 Nov;2(11):1051-8. doi: 10.1158/2326-6066.CIR-14-0154. Epub 2014 Sep 24. PMID 25252722