Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase I Trial of TG02 Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of TG02 Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Background:
TG02 is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors.
Objective:
To find out if TG02 is safe, and to find out if it in combination with TMZ is as effective as TMZ alone in people with brain tumors.
Eligibility:
People ages 18 and older with a brain tumor that has progressed after standard treatment
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
MRI of the brain if they have not had one in 14 days
Heart test
Tissue sample from prior surgeries
Participants will take TG02 plus TMZ by mouth in 28-day cycles.
Some will take TMZ for 7 days on and 7 days off. Others will take it every day.
They will all take TG02 three days before Cycle 1, and then on four days during every cycle.
They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after each TG02 dose.
They will all keep a diary of when they take the drugs and their symptoms.