Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

In brief

This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00039494

Run by

National Cancer Institute (NCI)

People needed

171

Starts

2002-12-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of 1 of the following:
• Glioblastoma multiforme (grade 4 astrocytoma)
• Gliosarcomas
• Other grade 4 astrocytoma variants (e.g., giant cell)
• Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• At least 6 months
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ upper limit of normal (ULN)
• AST no greater than 2.5 times ULN
• Creatinine no greater than 1.5 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No inability to take oral medications
• No requirement for IV alimentation
• No active uncontrolled peptic ulcer disease
• No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
• No prior allergy or intolerance to dacarbazine

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Northeast Georgia Cancer Care LLC — Athens, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Saint Anthony Memorial Hospital — Effingham, Illinois, United States
• Eureka Hospital — Eureka, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Illinois CancerCare Galesburg — Galesburg, Illinois, United States
• Western Illinois Cancer Treatment Center — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hopedale Medical Complex - Hospital — Hopedale, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Kewanee Hospital — Kewanee, Illinois, United States
• Mcdonough District Hospital — Macomb, Illinois, United States
• Garneau, Stewart C MD (UIA Investigator) — Moline, Illinois, United States
• Porubcin, Michael MD (UIA Investigator) — Moline, Illinois, United States
• Sharis, Christine M MD (UIA Investigator) — Moline, Illinois, United States
• Stoffel, Thomas J MD (UIA Investigator) — Moline, Illinois, United States
• Vigliotti, Antonio, P.G. M.D. (UIA Investigator) — Moline, Illinois, United States
• Bromenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center Foundation — Normal, Illinois, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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