Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hussein Tawbi; University of Pittsburgh
• Collaborators: Eisai Inc.; Schering-Plough
• Treatments: Azacitidine; Dacarbazine; Decitabine; Temozolomide

Criteria

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.