Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

NCT00054496 | Unknown Phase 2

• 2 other identifiers: CDR0000270723CCF-IRB-5478
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Response rate

Secondary Outcomes (4)

• Progression-free survival

• Overall survival

• Efficacy of erlotinib in inhibiting epidermal growth factor receptor (EGFR) signaling

• Efficacy of tumor EGFR amplification in predicting response to treatment

Interventions

erlotinib hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael A. Vogelbaum, MD, PhD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: August 1, 2002
• Last Updated: January 10, 2014

Record last verified: 2006-12

Locations

US (1)