Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00128700

Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy together with vatalanib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of vatalanib when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide Drug: vatalanib Procedure: adjuvant therapy Procedure: radiation therapy	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Phase I/II Study on Concomitant and Adjuvant Temozolomide and Radiotherapy With or Without PTK787/ZK222584 in Newly Diagnosed GBM

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Dose-limiting toxicity and maximum tolerated dose of vatalanib as determined by CTCAE v3.0 during phase I [ Designated as safety issue: Yes ]
Progression-free survival at 6 months during phase II [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severe toxic events as assessed by CTCAE v3.0 at weeks 3 and 6 (concomitant treatment), weeks 2 and 4 after radiotherapy, before each course of adjuvant treatment, monthly during maintenance treatment, and every 3 months during follow-up in phase II [ Designated as safety issue: Yes ]
Overall survival at 1 year during phase II [ Designated as safety issue: No ]
Correlation of angiogenesis and hypoxia markers expression and O-6-methylguanine DNA methyltransferase (MGMT) methylation status with clinical outcome during phase II [ Designated as safety issue: No ]

Estimated Enrollment:	219
Study Start Date:	June 2005
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed glioblastoma multiforme
- Newly diagnosed disease
Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator

PATIENT CHARACTERISTICS:

Age

18 to 69

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin < 1.5 times upper limit of normal (ULN)
Alkaline phosphatase < 2.5 times ULN
ALT and AST < 2.5 times ULN

Renal

Creatinine ≤ 1.7 mg/dL

Cardiovascular

Cardiac function clinically normal
12-lead ECG normal
No ischemic heart disease within the past 6 months
No uncontrolled cardiac arrhythmia
No uncontrolled hypertension
No history of stroke
No history of congenital long QT syndrome
QTc interval ≤ 450 msec for males or ≤ 470 msec for females by 12-lead ECG

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma in situ of the cervix
No active uncontrolled infection
No other unstable systemic disease
No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior anti-vascular endothelial growth factor therapy

Chemotherapy

No prior chemotherapy

Endocrine therapy

Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry

Radiotherapy

No prior radiotherapy

Surgery

More than 8 days, but < 6 weeks, since prior surgery or biopsy

Other

No prior randomization on this study
No concurrent warfarin, warfarin-derived drugs, or similar anticoagulants
No other concurrent anticancer therapy
No other concurrent investigational agents
No concurrent enzyme inducing antiepileptic drugs, including any of the following:
- Carbamazepine
- Fosphenytoin
- Oxcarbazepine
- Phenobarbital
- Phenytoin
- Primidone
No concurrent grapefruit or grapefruit juice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128700

Locations

Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Germany
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3075 EA
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Alba A. Brandes, MD

Azienda Ospedaliera di Padova

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Brandes AA, Stupp R, Hau P, et al.: EORTC Study 26041-22041: phase I/II study on concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) with or without PTK787/ZK222584 (PTK/ZK) in newly diagnosed glioblastoma: results of a phase I trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2026, 2007.

Study ID Numbers:	CDR0000437140, EORTC-26041, EORTC-22041, EUDRACT-2004-003896-35
Study First Received:	August 8, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00128700
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Temozolomide
Vatalanib
Neuroectodermal Tumors
Glioblastoma multiforme

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009