Status:
COMPLETED
Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma
Lead Sponsor:
Hussein Tawbi
Collaborating Sponsors:
Eisai Inc.
Schering-Plough
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.
Detailed Description
Primary Objectives: * Phase I: To determine the safety, tolerability, and Phase II recommended dose of the combination of extended schedule TMZ and DAC. * Phase II: To determine the efficacy, as meas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00715793
Start Date
June 1 2008
End Date
August 1 2015
Last Update
October 3 2017
Active Locations (1)
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1
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232