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Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma

NCT00811759 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2010-10-07

No results posted yet for this study

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

DRUG

sorafenib tosylate

DRUG

temozolomide

GENETIC

gene expression analysis

GENETIC

mutation analysis

OTHER

laboratory biomarker analysis

OTHER

pharmacological study

PROCEDURE

biopsy

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Caroline Robert, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-05-31

Countries

  • France

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 NCT00811759 on ClinicalTrials.gov