We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00385853
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : October 21, 2013
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Tracy T. Batchelor, MD, Massachusetts General Hospital

Brief Summary:
PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy. With this study, we would like to examine the effects of PTK when used in combination with radiation therapy and the anti-cancer drug temozolomide, the standard treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the study drug is absorbed, distributed, and cleared from the body.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: PTK787/ZK 222584 Drug: Temozolomide Procedure: Radiation Therapy Phase 1

Detailed Description:
  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of PRK787/ZK 222584 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma
Study Start Date : September 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: PTK787
Single arm study of PTK787
Drug: PTK787/ZK 222584
Twice daily for each 28-day cycle

Drug: Temozolomide
Daily for each 28-day cycle

Procedure: Radiation Therapy
For 7 weeks beginning on day 5 of the first treatment cycle

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Determine the pharmacologic profile of PTK787/ZK 222584 in this patient population [ Time Frame: 2 years ]
  2. determine the overall survival of patients with recurrent GM treated with PTK787/ZK 222584, when combined with temozolomide and radiation therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 protocol
  • 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 excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385853

Layout table for location information
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Layout table for investigator information
Principal Investigator: Tracy Batchelor, MD Massachusetts General Hospital
Publications of Results:
Layout table for additonal information
Responsible Party: Tracy T. Batchelor, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00385853    
Other Study ID Numbers: 06-013
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013
Keywords provided by Tracy T. Batchelor, MD, Massachusetts General Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors