Glioblastoma Clinical Trial
Official title:
A Phase I Evaluation of SCH 900105 With Correlative Tissue Studies in the Treatment of Adult Patients With Recurrent Glioblastoma
The goal of this clinical research study is to find the highest tolerable dose of SCH 900105 that can be given to patients with glioblastoma before surgery. The safety of this drug will also be studied.
The Study Drug:
SCH 900105 is designed to block the activity of one of the tumor-causing proteins
responsible for the development and uncontrolled growth of tumor cells and the formation of
new blood vessels. This may result in shrinking or stopping tumor growth.
You will need to take SCH 900105 for 14 days before surgery. If the doctor decides there is
a risk from the delay of surgery, you will not be able to take part in this study.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of SCH 900105 based on when you joined this study. Up to 3 dose levels (Dose Levels 0,
1, and 2) of SCH 900105 will be tested before surgery. Three (3) participants will be
enrolled at each dose level. The first group of participants will receive the lowest dose
level (Dose Level 0). Each new group will receive a higher dose than the group before it, if
no intolerable side effects were seen. This will continue until the highest tolerable dose
of SCH 900105 is found.
No matter what dose level you are assigned before surgery, all participants will receive
Dose Level 1 of SCH 900105 after surgery.
The amount of study drug you receive may change if you experience side effects. If at any
time you experience any intolerable side effects, tell the study doctor right away.
Study Drug Administration:
Cycle 1 will be 30 days and each following cycle will be 28 days.
If you are assigned to Dose Levels 0 or 2, you will receive SCH 900105 by vein over about 1
hour on Days 1, 8, and 15 of Cycle 1.
If you are assigned to Dose Level 1, you will receive SCH 900105 by vein over about 1 hour
on Days 1 and 15 of Cycle 1.
As a part of standard of care, you will have a surgery to remove the regrown tumor on Day 16
of Cycle 1. You will sign a separate consent for this surgery, which will describe the
procedure and its risks in detail.
You will not receive SCH 900105 for about 2 weeks after surgery. After 2 weeks, you will
receive SCH 900105 by vein on Days 1 and 15 of each cycle (Cycles 2 and beyond).
Study Visits:
At every visit, you will be asked about any drugs you may be taking and if you have
experienced any side effects.
On Days 1, 8, 15, and 22 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine
tests.
On Day 17 of Cycle 1, you will have an MRI scan to check the status of the disease.
On Day 1 of Cycles 2 and beyond:
- Your complete medical history will be recorded. You will have a physical exam,
including measurement of your weight and vital signs.
- You will have a neurological exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
On Day 15 of Cycles 2 and beyond, blood (about 2 teaspoons) will be drawn for routine tests.
On Day 1 of every other cycle starting Cycle 3 (Cycles 3, 5, 7, and so on), you will have an
MRI scan to check the status of the disease.
Pharmacokinetic (PK) and Biomarker Tests:
Extra blood will be drawn for PK testing and biomarker testing. PK testing measures the
amount of study drug in the body at different time points. These tests are for research
only.
Blood (about 1 teaspoon each time) will be drawn during the following times for PK testing:
- On Day 1 of Cycle 1, blood will be drawn 4 times.
- On Day 15 of Cycle 1, blood will be drawn 3 times.
- On Days 16, 17, and 19 of Cycle 1, blood will be drawn 1 time.
- On Day 1 of Cycles 2 and beyond, blood will be drawn 1 time.
- At 45 and 60 days after the last dose of SCH 900105, blood will be drawn 1 time.
- If you are assigned to Dose Levels 0 or 2, blood will also be drawn 2 times on Day 8 of
Cycle 1.
Blood (about 2 teaspoons each time) will be drawn during the following times for biomarker
testing:
- On Days 1 and 15 of Cycle 1, blood will be drawn 1 time.
- On Day 1 of Cycles 2 and beyond, blood will be drawn 1 time.
- If you are assigned to Dose Levels 0 or 2, blood will also be drawn 1 time on Day 8 of
Cycle 1.
Leftover tumor tissue (removed during your surgery on Day 16 of Cycle 1) will be collected
and used for PK tests and biomarker tests.
Length of Study:
You may continue receiving SCH 900105 for as long as you are benefitting. You will be taken
off study if the disease gets worse or you experience intolerable side effects.
This is an investigational study. SCH 900105 is not FDA approved or commercially available.
At this time, SCH 900105 is only being used in research.
Up to 21 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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