Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

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

Summary

RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

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

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme

• Radiographic evidence of recurrence or progression

• Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor

• Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

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

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

Hepatic

• Bilirubin no greater than 2 times normal

• Alkaline phosphatase no greater than 2 times normal

• ALT no greater than 3 times normal

Renal

• BUN no greater than 1.5 times normal OR

• Creatinine no greater than 1.5 times normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No medical condition that would interfere with oral administration of erlotinib

• No other medical or psychiatric illness that would preclude study therapy

• No active infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy for brain cancer

• No concurrent biologic therapy for brain cancer

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No concurrent chemotherapy for brain cancer

Endocrine therapy

• Concurrent glucocorticosteroids allowed

• No concurrent hormonal therapy for brain cancer

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• No prior epidermal growth factor receptor (EGFR) inhibitor

• No concurrent EGFR inhibitor

• No other concurrent antineoplastic therapy

• No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:

• Gabapentin

• Lamotrigine

• Divalproex

• Felbamate

• Levetiracetam

• Tiagabine

• Topiramate

• Zonisamide