Clinical trial NCT00045110 (phase 1/phase 2, status: completed)
Conditions: adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult grade i meningioma, adult grade ii meningioma, adult grade iii meningioma, recurrent adult brain tumor
ICD codes: C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66, C84.67, C84.77, C84.7A, C84.60, C84.70, C84.62, C84.66, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  One of the following diagnoses:

               -  Histologically confirmed intracranial malignant glioma

                    -  Glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic
                       oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant
                       astrocytoma not otherwise specified

                    -  Original histology of low-grade glioma allowed provided a subsequent
                       histology of malignant glioma is confirmed

               -  Histologically or radiographically confirmed recurrent or progressive benign or
                  malignant meningioma

          -  Progressive disease or tumor recurrence on MRI or CT scan

               -  Phase I: No more than 3 prior relapses and no more than 2 prior chemotherapy* or
                  biologic therapy regimens

               -  Phase II: No more than 2 prior relapses and no more than 2 prior chemotherapy* or
                  biologic therapy regimens

          -  Patients with progressive disease must have failed prior radiotherapy* that was
             completed at least 4 weeks ago

               -  Patients with progressive disease between 4 and 12 weeks after completion of
                  external beam radiotherapy must have clear evidence of progression on MRI

               -  Patients with GBM who have completed external beam radiotherapy and do not show
                  progression are eligible

               -  Patients with progressive disease after interstitial brachytherapy or
                  stereotactic radiosurgery must have confirmed true progression rather than
                  radiation necrosis based upon positron-emission tomography, thallium scanning,
                  MRI, or surgical documentation

          -  Measurable or evaluable disease

          -  Performance status - Karnofsky 60-100%

          -  More than 8 weeks

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 mg/dL (transfusion allowed)

          -  Bilirubin less than 1.5 times upper limit of normal (ULN)

          -  SGOT less than 1.5 times ULN

          -  Creatinine less than 1.5 mg/dL

          -  None of the following ophthalmic abnormalities:

               -  Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)

               -  Congenital abnormality (e.g., Fuch's dystrophy)

               -  Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or
                  Bengal-Rose)

               -  Abnormal corneal sensitivity test (Schirmer test or similar tear production test)

          -  Patients found to have dry eyes on examination but have an otherwise normal
             examination allowed

          -  No active infection

          -  No other serious concurrent medical illness

          -  No other malignancy within the past 3 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No other disease that would obscure toxicity or dangerously alter drug metabolism

          -  No significant medical illness that would preclude study participation

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for 12 weeks
             after study participation

          -  See Disease Characteristics

          -  At least 1 week since prior thalidomide

          -  At least 1 week since prior interferon

          -  At least 4 weeks since prior SU5416 or other experimental biologic agents

          -  See Disease Characteristics

          -  No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel
             wafers]) for patients with stable GBM

          -  At least 2 weeks since prior vincristine

          -  At least 3 weeks since prior procarbazine

          -  At least 6 weeks since prior nitrosoureas

          -  At least 1 week since prior tamoxifen

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

          -  No more than 6 weeks since prior external beam radiotherapy for patients with GBM
             without evidence of progression

          -  Recovered from prior surgery

          -  Recovered from prior therapy

          -  At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except
             radiosensitizers

          -  At least 4 weeks since prior cytotoxic therapy

          -  At least 4 weeks since prior tipifarnib or imatinib mesylate

          -  No prior erlotinib or other epidermal growth factor receptor inhibitors

          -  No concurrent combination antiretroviral therapy for HIV-positive patients