Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma

NCT00301418 | Completed Phase 1 Results

• 1 other identifier: 501007705
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will offer a safe treatment for patients with relapsing recurring glioblastoma (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of response to Tarceva with particular genetic alterations including epidermal growth factor receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.

Conditions

Glioblastoma Multiforme; Anaplastic Astrocytoma

Keywords

Glioblastoma Multiforme; Anaplastic Astrocytoma; High Grade Glial Neoplasms; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Safety of Twice a Day Oral 150 mg Erlotinib Dosing

  Greater than or equal to Grade 2 Adverse Event

  duration of the trial

Secondary Outcomes (2)

• 6-month Progression Free Survival (PFS)

  Duration of the trial

• Overall Survival (OS)

  Duration of the trial

Study Arms (1)

Tarceva (Erlotinib)

EXPERIMENTAL

Drug: Erlotinib

Interventions

Erlotinib DRUG

Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.

Also known as: Tarceva, OSI-774

Tarceva (Erlotinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of ≥ 18 years of age.
• Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA). All patients will have samples of their tissue evaluated for EGFRvIII overexpression and PTEN loss.
• Patients with a histologically confirmed low grade brain tumor who relapse with an enhancing tumor on magnetic resonance imaging (MRI) can be evaluated for toxicity only.
• Patients must have at least one confirmed and evaluable tumor site.\*
• \*A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or computed tomography \[CT\] scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
• Patients must have a Karnofsky performance status ≥ 60% (or the equivalent Eastern Cooperative Oncology Group \[ECOG\] level of 0-2) and an expected survival of ≥ three months.
• No chemotherapy for six weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
• Patients must have adequate hematologic reserve with WBC ≥ 3000/mm3, absolute neutrophils ≥ 1500/mm3 and platelets ≥ 100,000/mm3. Patients who are on Coumadin must have a platelet count of ≥ 150,000/mm3
• Pre-enrollment chemistry parameters must show: bilirubin \< 1.5X the institutional upper limit of normal (IUNL); AST or ALT \< 2.5X IUNL and creatinine \< 1.5X IUNL.
• Pre-enrollment coagulation parameters (PT and PTT) must be ≤ 1.5X the IUNL.
• Concomitant Medications:
• Growth factor(s): Must not have received within 1 week of entry onto this study.
• Steroids: Systemic corticosteroid therapy is permissible in patients with centrail nervous system (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
• Study Specific: Patients on enzyme-inducing anticonvulsants will be changed to non-enzyme inducing anticonvulsants or will not be allowed on this study. Patients receiving proton pump inhibitor or H2 blockers will not be allowed on study. Patients taking antacids will be allowed on study although they should not take the antacid for two hours before or two hours after taking erlotinib.
• Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.

You may not qualify if:

• Previous treatment with Tarceva®.
• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
• Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.

Sponsors & Collaborators

• Northwell Health: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10075, United States

Location

Related Publications (1)

• Mellinghoff IK, Wang MY, Vivanco I, Haas-Kogan DA, Zhu S, Dia EQ, Lu KV, Yoshimoto K, Huang JH, Chute DJ, Riggs BL, Horvath S, Liau LM, Cavenee WK, Rao PN, Beroukhim R, Peck TC, Lee JC, Sellers WR, Stokoe D, Prados M, Cloughesy TF, Sawyers CL, Mischel PS. Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors. N Engl J Med. 2005 Nov 10;353(19):2012-24. doi: 10.1056/NEJMoa051918.

  PMID: 16282176 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Brain Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Boockvar, MD
• Organization: Feinstein Institute for Medical Research

jboockvar@northwell.edu

212-434-3900

Study Officials

• John A Boockvar, M.D.

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 10, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 10, 2016
• Results First Posted: February 10, 2016

Record last verified: 2016-01

Locations

US (1)