Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
Completed · Phase 1/Phase 2
Conditions studied: Malignant Melanoma
In brief
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
Key facts
- Study ID
- NCT00715793
- Run by
- Hussein Tawbi
- People needed
- 39
- Starts
- 2008-06-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2017-10-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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