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A Phase I Study of PRK787/ZK 222584 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma

Phase 1
18 Years
Not Enrolling

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Trial Information

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.

Inclusion Criteria:

- All patients must have histologically verified glioblastoma. Patients mus have
paraffin blocks of tumor that must be sent for analysis.

- 18 years of age or older

- Karnofsky Performance Status greater than or equal to 60

- Adequate laboratory values as described by the protocol

- Life expectancy of greater than 12 weeks

- Patient must be able to undergo serial MR imaging

- Patients must be on an enzyme-inducing anti-epileptic drug(s) as listed in the

- No steroids or a stable dose of steroids for at least 5 days or a decreasing dose

- Mini-mental status examination of 15 or greater

Exclusion Criteria:

- Pregnant or breast-feeding women

- Concurrent malignancy except curatively treated basal or squamous cell carcinoma of
the skin or carcinoma in situ of the cervix or breast

- Prior chemotherapy or cranial radiation therapy for glioblastoma

- Prior biologic or immunotherapy less than 2 weeks prior to registration

- If the patient surgery is more than 16 days or less than 13 days from the start of
PTK787/ZK 222854

- Prior therapy with anti-VEGF agents

- Pleural effusion or ascites that causes respiratory compromise

- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation is the study

- Impairment of gastrointestinal function or GI disease that may significantly alter
the absorption of PTK787/ZK 222584

- Confirmed diagnosis of human immunodeficiency virus (IV)

- Patients who are taking therapeutic warfarin sodium or other anticoagulants or
anti-platelet agents

- Patients requiring aprepitant, dolasetron, and tropisetron as antiemetics are

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Tracy Batchelor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

September 2011

Related Keywords:

  • Glioblastoma
  • PTK
  • temozolomide
  • glioblastoma
  • Glioblastoma



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617