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

NCT00715793 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-10-03

Study results available
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Summary

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

Conditions

  • Malignant Melanoma

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Hussein Tawbi

    lead OTHER

Principal Investigators

  • Hussein Tawbi, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715793 on ClinicalTrials.gov