Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 26, 2003

Keywords

ClinConnect Summary

PRIMARY OBJECTIVES:

I. To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy.

II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status.

III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839.

SECONDARY OBJECTIVES:

I. Whe...

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Eligibility criteria

• Inclusion Criteria:
• • Histopathologically confirmed glioblastoma multiforme (with areas of necrosis)
• • Diagnosis must be made by surgical biopsy or excision
• • The tumor must be supratentorial in location
• • The patient must have recovered from the effects of surgery, post-operative infection, or other complications before study entry
• • Radiotherapy must begin =\< five weeks after surgery, and Iressa (gefitinib) must begin one week prior to radiotherapy
• • Patients must have an estimated survival of at least 8 weeks
• • Zubrod performance status of 0-1
• • A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) scan must be performed preoperatively and postoperatively prior to the initiation of radiotherapy; preoperative and postoperative scans must be the same type
• • Patients diagnosed only by stereotactic biopsy do not require the postoperative scan
• • Patients unable to undergo magnetic resonance (MR) imaging because of non-compatible devices can be enrolled, provided pre and postoperative CT scans are obtained and are of sufficient quality
• • Hemoglobin \>= 10 grams
• • Absolute neutrophil count \>= 1500 (ANC) per mm\^3
• • Platelets \>= 100,000 per mm\^3
• • Blood urea nitrogen (BUN) =\< 25 mg
• • Creatinine =\< 1.5 mg
• • Bilirubin =\< 2.0 mg
• • Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =\< 2 x normal range
• • Patients must consent to submission of their tissue/serum
• • The patient must sign a study-specific informed consent prior to study entry; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member
• Exclusion Criteria:
• • Recurrent or multifocal malignant gliomas
• • Metastases detected below the tentorium or beyond the cranial vault
• • Major medical illnesses or psychiatric impairments which, in the investigator's opinion, will prevent administration or completion of protocol therapy
• • Previous radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
• • Active connective tissue disorders, such as lupus or scleroderma which, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity
• • Previous malignancies, except for non-melanomatous skin cancers and carcinoma in situ of the uterine cervix or bladder, unless disease-free for \>= 3 years
• • Prior chemotherapy or radiosensitizers for cancers of the head and neck region
• • Patients with known acquired immune deficiency (AIDS); patients with AIDS require complex therapeutic regimens; the pharmacokinetic interactions of these regimens with ZD 1839 are unknown and therefore, pose a safety risk related to excess toxicity or interference with anti-viral effectiveness
• • Patients with known multiple sclerosis, as these patients may have decreased tolerance for radiation therapy to the brain
• • Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug
• • Patients treated on any other clinical protocols within 30 days prior to study entry or during participation in the study