A Phase I Study of PRK787/ZK 222584 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma
- Since we are looking for the highest dose of PTK that can be administered safely
without severe or unmanageable side effects, not everyone who participates will get the
same dose of PTK. A small group will be enrolled onto the study and given a certain
dose. If they tolerate it well, the next small group enrolled will receive a higher
dose. This will continue until the highest dose that can be given without severe or
unmanageable side effects is found.
- Participants will receive PTK twice daily along with temozolomide daily during each
treatment cycle. Each treatment cycle lasts 28 days.
- PTK will start on Day 0 of the first cycle and will be given twice daily for the 7
weeks the participant receives radiation therapy.
- Daily doses of temozolomide will begin on Day of the first cycle and continue until
the last dose of radiation therapy in cycle 1.
- Each participant will receive 7 weeks of radiation therapy. Radiation therapy will
start on Day 5 of the first cycle and will be administered monday through friday,
except on holidays.
- When radiation stops, temozolomide and PTK will be given for a maximum of 6
post-radiation cycles of study treatment. During these cycles, PTK and temozolomide
will be given for 5 consecutive days followed by 23 days of no drugs.
- Tests will be performed routinely throughout the study treatment and include; chest
x-rays, blood tests, physical exams, urine tests and ECG.
- The following procedures will be performed at the end of the study or after the
participants last dose of study medication; tumor assessment by MRI, routine blood
draws, neurological/physical exam and, medical history review.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximal tolerated dose, safety and feasibility of PTK787/ZK 222584 in combination with temozolomide and radiation in patients with newly diagnosed glioblastoma.
Tracy Batchelor, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|