Glioblastoma Clinical Trial
Official title:
Phase II Portion of Trial of Dasatinib (Sprycel) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma
Phase II:
Primary Objectives:
-To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of
concomitant temozolomide (TMZ) administered at 75 mg/m^2/day followed by adjuvant
temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM)
as measured by overall survival.
Secondary Objectives:
- To determine the efficacy of this treatment as measured by radiographic response (RR),
progression-free survival (PFS) and time to progression (TTP).
- To characterize the safety profile of dasatinib (Sprycel) in combination with RT and
concomitant TMZ in patients with newly-diagnosed GBM.
- To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant
TMZ in patients with GBM after RT.
Exploratory Objectives:
-To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src,
EphA2, c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and
temozolomide.
PHASE II (Study did not progress from Phase I)
The Study Drugs:
Dasatinib is designed to change the function of certain genes. By changing the function of
these genes, it may prevent cancer from growing and spreading. It is also designed to block
or lower the activity of one or more tumor-causing proteins responsible for the uncontrolled
growth of tumor cells, which may result in shrinking or stopping tumor growth.
Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of
cells). The damaged DNA may cause tumor cell death.
PHASE II Study Drug Administration
Study Groups:
If found to be eligible to take part in this study, participant will be assigned to a dose
level of dasatinib based on when joined study. Up to 2 dose levels of dasatinib will be
tested. Three (3) participants will be enrolled at each dose level. The first group of
participants will receive the lowest dose level. 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 dasatinib given in combination with temozolomide is found.
All the groups will take the same dose level of temozolomide for the entire study.
The amount of study drugs received may change if participant experiences side effects. If at
any time participant experiences any intolerable side effects, tell the study doctor right
away.
Study Drug Administration:
During Radiation:
As a part of standard of care, participant will receive radiation therapy Monday-Friday for
a total of 30 radiation treatments (about 6 weeks).
Every day while participants are receiving radiation, they will take the temozolomide by
mouth once a day for up to a maximum of 7 weeks.
They should swallow temozolomide whole, one right after the other, without chewing them. If
vomit while taking temozolomide, participant cannot take more capsules before the next
scheduled dose. They should be taken on an empty stomach (at least 1 hour before and 2 hours
after eating) with 1 cup (about 8 oz.) of water.
Every day while receiving radiation, take dasatinib by mouth 1 time a day for up to a
maximum of 7 weeks. Participant should take dasatinib without food (1 hour before or 2 hours
after eating), with at least 1 cup (8 oz.) of water.
After Radiation:
After the radiation therapy ends, every day, participant will continually take dasatinib by
mouth 1 time a day.
They will not take temozolomide for about 4 weeks after the radiation therapy ends. After 4
weeks, they will begin taking temozolomide 1 time a day, by mouth, on Days 1-5 of each 28
day study cycle.
Study Visits:
Four (4) weeks after the end of radiation, then every 4 weeks after that, the following
tests and procedures will be performed:
- They will have a physical exam, including measurement of vital signs.
- They will have a neurological exam.
- They will have a performance status evaluation.
- They will be asked about any drugs they may be taking and if they have experienced any
side effects.
- Blood (about 1 teaspoon) will be drawn to check blood's ability to clot normally.
Every week for the first 6 weeks, then every 4 weeks after that, they will be asked if have
experienced any side effects.
If they are taking an anti-seizure drug, every 2 weeks for the first 6 weeks and then every
4 weeks after that, blood (about 1 teaspoon) will be drawn to check the levels of
anti-seizure drug in blood.
At Week 6, then before each cycle after radiation for the first 6 cycles, they will have an
ECG.
Every week for the first 6 weeks, then on Days 1 and 22 of every cycle after radiation,
blood (about 3 teaspoons) will be collected for routine tests.
Four (4) weeks after the end of radiation, then every 8 weeks after that, they will have an
MRI scan to check the status of the disease.
Length of Study:
They may continue taking temozolomide for up to 12 cycles. They may continue taking
dasatinib for as long as benefitting. they will be taken off study early if the disease gets
worse or experience intolerable side effects.
End-of-Study Visit:
After going off study, they will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:
- Complete medical history will be recorded.
- They will have a physical exam.
- They will have a performance status evaluation.
- They will be asked about any drugs they may be taking and if they have experienced any
side effects.
- They will have a neurological exam.
- Blood (about 3 1/2 teaspoons) will be collected for routine tests and to check blood's
ability to clot normally.
- If they are taking an anti-seizure drug, blood (about 1 teaspoon) will be drawn to
check the level of anti-seizure drug in blood.
Long-Term Follow-up visit:
After the end-of-study visit, the study team/staff will contact participants by telephone
every 3 months to check how participants are doing. Each phone call will take about 5
minutes.
This is an investigational study. Temozolomide is FDA approved and commercially available
for the treatment of brain tumors. Dasatinib is FDA approved and commercially available for
the treatment of some types of leukemia, but it is experimental for use in brain tumors. In
addition, the combination of temozolomide and dasatinib is experimental for use in brain
tumors. At this time, the combination is only being used in research.
Up to 72 participants will take part in this study. Up to 72 will be enrolled at M. D.
Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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