Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Dacarbazine; Temozolomide; Vatalanib

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