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

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

Summary

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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

• No other active malignancy requiring treatment

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior chemotherapy for any brain tumor

• No prior temozolomide

• No prior radiotherapy for any brain tumor

• No other concurrent investigational agents

• More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection)

• No prior surgical procedures affecting absorption

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent warfarin