Bevacizumab, Temozolomide, and External Beam Radiation Therapy as First-Line Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

NCT01013285 | Completed Phase 2 Results DMC

• 5 other identifiers: 11-000558UCLA-0604016AVF3770sCDR0000628787GENENTECH-UCLA-0604016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with temozolomide and external beam radiation therapy works when given as first-line therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  2 years

Secondary Outcomes (4)

• Time to Disease Progression

  2 years

• Progression-free Survival at 6 Months

  6 months

• Radiographic Response (When Evaluable)

  2 years

• Median Overall Survival (OS) Based on the MGMT Promoter Methylation Status

  2 years

Study Arms (1)

bevacizumab, temozolomide, external beam radiation

EXPERIMENTAL

Biological: bevacizumab; Drug: temozolomide; Radiation: external beam radiation therapy

Interventions

bevacizumab BIOLOGICAL

bevacizumab, temozolomide, external beam radiation

temozolomide DRUG

bevacizumab, temozolomide, external beam radiation

external beam radiation therapy RADIATION

bevacizumab, temozolomide, external beam radiation

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma.
• Prior histologic diagnosis of low-grade glioma allowed provided it has been upgraded to GBM after repeat resection
• Has undergone surgery to collect tumor tissue 3-6 weeks ago
• Measurable or assessable disease is not required
• Karnofsky performance status 60-100%
• Life expectancy \> 8 weeks
• White Blood Cell (WBC) ≥ 3,000/mm³
• Absolute Neutrophil Count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• Serum Glutamate Oxaloacetate Transaminase (SGOT) \< 2.5 times upper limit of normal (ULN)
• Bilirubin \< 2.5 times ULN
• INR (international normalized ratio) ≤ 1.5 times ULN (except if on therapeutic anticoagulation therapy)
• aPTT (activated partial thromboplastin time) ≤ 1.5 times ULN (except if on therapeutic anticoagulation therapy)
• Creatinine \< 1.5 mg/dL

You may not qualify if:

• unstable angina
• BP \> 150/100 mm Hg
• New York Heart Association (NYHA) class II-IV congestive heart failure
• myocardial infarction within the past 6 months
• stroke within the past 6 months
• clinically significant peripheral vascular disease
• evidence of bleeding diathesis or coagulopathy
• intracerebral abscess within past 6 months
• abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• serious, non-healing wound, ulcer, or bone fracture
• Any wound requiring surgical intervention (including scalp wounds requiring cranioplasty) allowed provided the wound is clean and without further infection post-surgical intervention
• significant traumatic injury within the past 28 days
• concurrent serious uncontrolled medical illness including, but not limited to, the following:
• Ongoing or active infection requiring IV antibiotics
• Psychiatric illness/social situation that would limit compliance with study requirements

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center, University of California, Los Angeles (UCLA)

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Bevacizumab; Temozolomide

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Albert Lai
• Organization: UCLA Neuro-Oncology Program

albertlai@mednet.ucla.edu

310-825-5321

Study Officials

• Albert Lai, MD

  Ronald Reagan University of California, Los Angeles (UCLA) Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: June 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2015
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2016-04

Locations

US (1)