NCT00715793

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hussein Tawbi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 measured by overall response rate, of the combination of extended schedule TMZ and DAC given at the Phase II recommended dose to patients with metastatic melanoma. Secondary Objectives: * To determine pharmacokinetics of the combination of TMZ and DAC in patients with metastatic melanoma. * To determine, in peripheral blood mononuclear cells (PBMC) and tumor tissue, the pharmacodynamic effects of the combination of TMZ and DAC on promoter methylation and expression of selected genes and correlate these with response. * To determine the progression-free survival of patients treated with the combination of TMZ and DAC.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Decitabine	In Part I patients will be treated on a standard "3+3" phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle.
DRUG	Temozolomide	Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle.
PROCEDURE	biopsy	Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II.

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2008-07-15
• Last updated: 2017-10-03
• Results posted: 2017-10-03

Locations

1 site across 1 country: United States