Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients

NCT00527657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-11-14

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU, CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM) in the treatment of metastatic melanoma that has spread to the brain. The safety and effectiveness of this combination therapy will also be studied.

Conditions

Interventions

DRUG

Lomustine

Starting dose 30 mg/m\^2 by mouth daily on Day 1 and 29.

DRUG

Temozolomide

75 mg/m\^2 by mouth daily on Days 1 to 42.

DRUG

Thalidomide

200 mg/m\^2 by mouth daily.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nicholas E. Papadopoulos, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-09
Primary Completion
2012-02-02
Completion
2012-02-02

Countries

  • United States

Study Locations

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Entities

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 NCT00527657 on ClinicalTrials.gov