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Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT00715793•Hussein Tawbi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

May 1, 2015

Completion Date

August 1, 2015

Last Updated

October 3, 2017

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

Decitabine

DRUG

Temozolomide

DRUG

biopsy

PROCEDURE

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

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