Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma multiforme.

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

Details

• Lead Sponsor: David Peereboom
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Erlotinib Hydrochloride; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven glioblastoma multiforme

• Newly diagnosed disease

• Has undergone diagnostic biopsy or surgical resection within the past 28 days

PATIENT CHARACTERISTICS:

• ECOG 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin > 9 g/L

• Serum creatinine and total serum bilirubin < 1.5 times upper limit of normal (ULN)

• AST or ALT < 2.5 times ULN

• Alkaline phosphatase < 2.5 times ULN

• No other severe underlying disease (including HIV or chronic hepatitis B or C infection)

• Fertile patients must use effective contraception

• Not pregnant or nursing

• No medical condition that could interfere with the oral administration of temozolomide or erlotinib hydrochloride

• No other malignancy within the past 3 years with the exception of surgically cured carcinoma in situ of the cervix, nonmelanoma skin cancer, or adequately treated stage I or II cancer from which the patient is in complete remission

• No active infection

• No other condition that would preclude ability of the patient to be followed closely at the Cleveland Clinic

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy or chemotherapy for this cancer

• No prior cranial radiotherapy

• No concurrent enzyme-inducing anti-epileptic drugs

• No prior temozolomide or erlotinib hydrochloride

• No other concurrent antineoplastic therapy

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during chemotherapy

• No concurrent electron, particle, or implant boost radiotherapy

• No concurrent radiosurgery