Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients
NCT00527657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2018-11-14
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
- Brain Neoplasms
- Melanoma
Interventions
- DRUG
-
Lomustine
Starting dose 30 mg/m\^2 by mouth daily on Day 1 and 29.
- DRUG
-
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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