A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme
Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may
help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug
that was designed to stop cancer cells from dividing.
All participants will take thalidomide capsules by mouth every evening at bedtime. You
will begin with 1 capsule every night for the first week then increase to 2 capsules every
night for a week and then 3 capsules a night for the third week. After that, you will
increase the dose to 4 capsules each night for the rest of the study. The dosages may be
adjusted if you experience any severe side effects.
In addition to thalidomide, you will receive treatment with CPT-11 through a continuous
injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest
from the drug. This 6 week period is called a course of therapy. The courses of therapy
will be repeated as long as the disease is responding to treatment for up to 2 years.
THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and
CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs
Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.
Is there an age limit? No
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Progression Free at 6 Months With Malignant Gliomas
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Vinay K. Puduvalli, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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