What side effects are associated with this type of intervention?

Bevacizumab, an angiogenesis inhibitor, commonly causes hypertension, proteinuria, and increased risks of bleeding and thromboembolic events. Temozolomide, an alkylating agent, often leads to myelosuppression, resulting in thrombocytopenia, neutropenia, and anemia. Additional side effects of Temozolomide include nausea, vomiting, fatigue, and a heightened risk of infections due to immunosuppression.

What prior FDA approvals exist?

Bevacizumab, an angiogenesis inhibitor, was approved by the FDA for the treatment of recurrent Glioblastoma in 2009. It works by inhibiting the growth of blood vessels that supply the tumor. Temozolomide, an oral alkylating agent, was approved by the FDA in 2005 for the treatment of newly diagnosed Glioblastoma in combination with radiotherapy and as maintenance therapy. Temozolomide works by methylating DNA, which leads to tumor cell death. These treatments are significant as they target tumor growth through different mechanisms, providing a multifaceted approach to Glioblastoma management.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment include ONC201, an investigational oral compound targeting mitochondrial metabolism and stress response pathways, and DNX-2401, an oncolytic adenovirus administered locally. Additionally, immunotherapy approaches such as CAR T-cell therapy targeting GD2 and PD-1 blockade with nivolumab are being explored.

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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

Must not have

Unstable angina

Blood pressure of > 150/100 mmHg, history of hypertensive crisis or hypertensive encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of bevacizumab and temozolomide in older patients with newly diagnosed aggressive brain tumors. Bevacizumab blocks the tumor's blood supply, and temozolomide damages the cancer cells' DNA to stop them from growing. These two drugs have been studied together in various trials for glioblastoma, showing potential benefits and safety concerns.

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.

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.

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

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I agree not to take other cancer drugs while on bevacizumab and temozolomide.

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I will start temozolomide 2-6 weeks and bevacizumab 4-6 weeks after my cancer surgery.

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I can care for myself but may need occasional help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unstable chest pain.

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My blood pressure is over 150/100 mmHg, or I've had a severe hypertension crisis.

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I haven't had major surgery or significant injury, excluding brain surgery, in the last 28 days.

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I have not had a stroke in the last 6 months.

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I do not have any serious illnesses that are not under control.

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I have heart failure that affects my daily activities.

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I had a heart attack less than 6 months ago.

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I do not have a bleeding disorder or significant blood clotting issues without taking blood thinners.

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I have coughed up a noticeable amount of bright red blood recently.

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I have not had radiation therapy to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

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%

Stomach pain

33%

Aspartate aminotransferase (AST) increased

33%

Neuropathy, Cranial (Pupil, Upper eyelid)

33%

Neuropathy, Sensory Legs/Toes tingling

33%

Taste Alteration

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%

Study treatment Arm

Phase I: Vorinostat + Bevacizumab

Phase II: Bevacizumab

Phase II: Bevacizumab + Vorinostat 400 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bevacizumab and Temozolomide are common treatments for Glioblastoma due to their complementary mechanisms of action. Bevacizumab inhibits angiogenesis by targeting VEGF, which prevents the formation of new blood vessels that the tumor needs to grow. Temozolomide, on the other hand, is an alkylating agent that methylates DNA, causing DNA damage and inducing apoptosis in tumor cells. This combination is significant for Glioblastoma patients as it aims to both starve the tumor of its blood supply and directly damage its DNA, potentially improving treatment efficacy and patient outcomes.