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Monoclonal Antibodies

Bevacizumab + Temozolomide for Glioblastoma

Phase 2
Waitlist Available
Led By Phioanh Nghiemphu
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be willing to forego other drug therapy against the tumor while being treated with bevacizumab and temozolomide
Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying bevacizumab and temozolomide to see how well they work compared to temozolomide alone in treating patients with glioblastoma multiforme or gliosarcoma that has come back or does not respond to treatment.

Who is the study for?
This trial is for older patients with newly-diagnosed glioblastoma multiforme or gliosarcoma. Participants must have adequate organ function, a Karnofsky performance status of >= 60, and no significant medical illnesses that could interfere with the treatment. They should not have had other cancer treatments (except certain types) in the last 3 years and cannot be on other experimental drug studies.Check my eligibility
What is being tested?
The study is testing how well bevacizumab (a monoclonal antibody that blocks tumor growth) works when given together with temozolomide (a chemotherapy drug). The goal is to see if this combination is more effective in stopping tumor growth compared to current treatments.See study design
What are the potential side effects?
Potential side effects include high blood pressure, bleeding or clotting issues, wound healing complications, gastrointestinal problems like perforation or abscesses, increased risk of stroke or heart problems due to vascular disease, and possible allergic reactions to the components of bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree not to take other cancer drugs while on bevacizumab and temozolomide.
Select...
I will start temozolomide 2-6 weeks and bevacizumab 4-6 weeks after my cancer surgery.
Select...
I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Time to progression
progression free survival

Side effects data

From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031
100%
Headache
100%
Fatigue
83%
Lymphocyte count decreased
83%
Hemoglobin Increase
83%
Nausea
83%
Platelet count decreased
67%
Memory impairment
67%
Bicarbonate Serum-low
67%
Constipation
67%
Dizziness
67%
Gait disturbance
67%
Pyramidal Tract Dysfunction
50%
Hypoalbuminemia
50%
Hyponatremia
50%
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)
50%
METABOLIC/LABORATORY (elevated LDH)
50%
Edema limbs
50%
Leukocytosis
50%
METABOLIC/LABORATORY (Elevated BUN)
50%
Mood Alteration
50%
Speech Impairment
33%
Neuropathy, Sensory Legs/Toes tingling
33%
Neuropathy, Cranial (Pupil, Upper eyelid)
33%
Aspartate aminotransferase (AST) increased
33%
Taste Alteration
33%
Stomach pain
33%
Diplopia
33%
Muscle weakness- Whole body/generalized
33%
OCULAR/VISUAL (Right & Left visual field deficits)
33%
Hypokalemia
33%
Hypophosphatemia
33%
Alanine aminotransferase (ALT) increased
33%
Alkaline phosphatase increased
33%
Anorexia
33%
Bruising
33%
Confusion
33%
Diarrhea
33%
Gait/walking (wide based ataxic hemiparetic)
33%
Hyperglycemia
33%
Hypoglycemia
33%
METABOLIC/LABORATORY (low creatinine)
33%
METABOLIC/LABORATORY (low protein)
33%
Muscle weakness lower extremity
33%
Seizure
33%
Somnolence
17%
Dehydration
17%
DECUBITUS Ulcer Sacrum
17%
Hyperuricemia
17%
Allergic rhinitis
17%
Bloating
17%
Irregular Menses
17%
Pain (Neuropathic in perineal/buttock)
17%
Heartburn
17%
Hypocalcemia
17%
Mental Status Altered
17%
Infection with Normal ANC (Neck NOS), cellulitis
17%
METABOLIC/LABORATORY (low chloride)
17%
Mucositis oral
17%
Obstruction GI (STOMACH-small bowel nos)
17%
Epistaxis
17%
Tremor
17%
Blood bilirubin increased
17%
Blurred vision
17%
Cholesterol high
17%
Creatinine increased
17%
Cushingoid
17%
Bump at sutura site
17%
Multiple scabs
17%
Dysphagia
17%
Edema cerebral
17%
Gait/walking Impaired mobility
17%
Gastrointestinal (sensitivity to smell)
17%
Hiccups
17%
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum
17%
Joint Pain
17%
METABOLIC/LABORATORY (high chloride)
17%
METABOLIC/LABORATORY (low uric acid)
17%
OCULAR SURFACE DISEASE
17%
OCULAR/VISUAL (Right homonymous hemianopsia)
17%
PAIN (BACK)
17%
Pain in extremity
17%
Pruritus
17%
Sinus bradycardia
17%
Voice alteration
17%
Weight loss
17%
Sensory loss left side
17%
Dyspnea
17%
Vomiting
17%
Hypertriglycedidemia
17%
Infection with Normal ANC (Neck NOS), herpes zoster
17%
Insomnia
17%
Neuropathy, Numbness, Right sided
17%
Sore throat
17%
Urinary tract infection
17%
Hyperpigmentation (hands & knuckles)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Vorinostat + Bevacizumab
Phase II: Bevacizumab
Phase II: Bevacizumab + Vorinostat 400 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment6 Interventions
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
temozolomide
2008
Completed Phase 2
~1060
bevacizumab
2002
Completed Phase 3
~3360
microarray analysis
2006
Completed Phase 3
~3600
DNA methylation analysis
2007
Completed Phase 3
~2210

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,639 Total Patients Enrolled
34 Trials studying Glioblastoma
1,916 Patients Enrolled for Glioblastoma
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,025 Total Patients Enrolled
17 Trials studying Glioblastoma
476 Patients Enrolled for Glioblastoma
Phioanh NghiemphuPrincipal InvestigatorUniversity of California at Los Angeles (UCLA )
1 Previous Clinical Trials
1 Trials studying Glioblastoma

Media Library

Glioblastoma Research Study Groups: Arm I

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can patients sign up for this experimental program?

"Unfortunately, this particular study is no longer recruiting patients. Our records show that it was initially posted on 4/28/2010 and last updated on 2/10/2022. However, if you are interested in other trials, there are 579 studies for bevacizumab and 459 trials actively searching for participants with glioblastoma."

Answered by AI

What are the potential risks associated with bevacizumab?

"While bevacizumab has yet to demonstrate efficacy in clinical trials, it has been shown to be safe and received a score of 2."

Answered by AI

Are there comparable tests that have used bevacizumab in the past?

"As of now, 579 different clinical trials are still ongoing for bevacizumab. Out of these, 122 have reached Phase 3. With the majority of these tests taking place in Taibei, Taiwan, there are a total of 23510 locations running bevacizumab trials."

Answered by AI

Is bevacizumab typically used to prevent or treat a specific condition?

"Bevacizumab is a versatile medication, and it is frequently used to treat disease progression and malignant neoplasms. Additionally, bevacizumab can help manage recurrent platinum sensitive primary peritoneal cancer and advance directives."

Answered by AI

Is this the initial clinical research project of its variety?

"Since 2002, bevacizumab has been under investigation in 579 active clinical trials spread out over 2063 cities and 66 countries. The first study was conducted by Schering-Plough and involved 60 patients. After the completion of the initial trial, bevacizumab received Phase 2 drug approval."

Answered by AI

How many people are in this clinical trial?

"This clinical trial is not presently looking for participants at this time. The trial was first posted on 4/28/2010 and was last edited on 2/10/2022. If you are exploring for other studies, there are currently 459 clinical trials actively admitting participants with glioblastoma and 579 trials for bevacizumab actively looking for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma
2010. "Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01149850.
~3 spots leftby Apr 2025
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