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

NCT00385853 | Completed Phase 1 DMC

• 1 other identifier: 06-013
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma

Keywords

PTK; temozolomide; glioblastoma

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (2)

• Determine the pharmacologic profile of PTK787/ZK 222584 in this patient population

  2 years

• determine the overall survival of patients with recurrent GM treated with PTK787/ZK 222584, when combined with temozolomide and radiation therapy.

Study Arms (1)

PTK787

EXPERIMENTAL

Single arm study of PTK787

Drug: PTK787/ZK 222584; Drug: Temozolomide; Procedure: Radiation Therapy

Interventions

PTK787/ZK 222584 DRUG

Twice daily for each 28-day cycle

PTK787

Temozolomide DRUG

Daily for each 28-day cycle

PTK787

Radiation Therapy PROCEDURE

For 7 weeks beginning on day 5 of the first treatment cycle

PTK787

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Novartis: collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Gerstner ER, Eichler AF, Plotkin SR, Drappatz J, Doyle CL, Xu L, Duda DG, Wen PY, Jain RK, Batchelor TT. Phase I trial with biomarker studies of vatalanib (PTK787) in patients with newly diagnosed glioblastoma treated with enzyme inducing anti-epileptic drugs and standard radiation and temozolomide. J Neurooncol. 2011 Jun;103(2):325-32. doi: 10.1007/s11060-010-0390-7. Epub 2010 Sep 7.

  PMID: 20821342 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

vatalanib; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Tracy Batchelor, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

US (2)