Clinical trial · Interventional
Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
Phase I/II Trial of the Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
NCT00715793CI-TRIAL-00029758UPCI-07-008completedPhase 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
Summary
Brief summary (as posted)
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: Decitabine
- Drug: Temozolomide
- Procedure: biopsy
Primary outcomes (3)
- measure
- Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT)
- timeFrame
- Up to 26 months
- description
- Dose-limiting toxicities (DLTs) were defined as grade 4 neutropenia or thrombocytopenia which lasts \>7 days; grade 3 or 4 febrile neutropenia; grade 3 or greater non-hematological toxic effects.
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 30 months
- description
- Using RECIST v1.0 criteria, overall response rate (ORR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD), multiplied by 100. Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have progressed despite prior therapies. * Life expectancy of at least 12 weeks. * ECOG performance status of 0, 1 and 2. * ≥18 years of age. * Patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration. * First line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks or \>2 weeks if treated with stereotactic radiosurgery, remain eligible) Exclusion Criteria: * Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of \<60 ml/min). * Impaired hepatic function (liver enzymes greater than twice the upper limit of normal or bilirubin \> 2.0 except in patients with Gilbert's syndrome). * Prior treatment with alkylating agents (including TMZ and DTIC). * Active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks remain eligible). * Active infections or serious general medical conditions. * Female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.