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Chemotherapy + Radiation for Brain Cancer

Phase 2

Recruiting

Led By Debra N Yeboa

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma [GBM])

Be older than 18 years old

Must not have

Leptomeningeal disease

New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well temozolomide and radiation therapy work in treating patients with IDH wildtype lower grade gliomas or non-histological molecular glioblastomas.

Who is the study for?

This trial is for patients with specific brain tumors called IDH wildtype gliomas or molecular glioblastomas, who haven't had chemotherapy or radiotherapy before. They should be able to undergo MRI scans, have a good performance status (able to carry out daily activities), and their blood counts and liver function tests need to be within certain limits.

What is being tested?

The study is testing the effectiveness of combining temozolomide (a chemotherapy drug) with radiation therapy in treating these brain tumors. The goal is to see if this combination works better than previous standard treatments in controlling the disease.

What are the potential side effects?

Temozolomide can cause side effects like nausea, vomiting, fatigue, hair loss, constipation, headache and seizures. Radiation therapy may lead to tiredness, skin irritation at the treatment site, headaches and could potentially affect memory or other cognitive functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is a high-grade glioma or glioblastoma without IDH mutation.

Exclusion Criteria

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

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My cancer has spread to the lining of my brain and spinal cord.

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I was hospitalized for heart failure that affects my daily activities within the last year.

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My diagnosis is either gliosarcoma (grade IV) or pilocytic astrocytoma (grade I).

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I have a serious heart rhythm problem that is not well-controlled.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I do not have a severe lung condition that requires hospital care right now.

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I have severe kidney disease requiring dialysis.

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I have had chemotherapy or radiotherapy for a brain tumor before.

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I have had radiation therapy to my head or neck before.

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My brain cancer is present in multiple areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Progression free survival (PFS)

Secondary study objectives

Overall survival (OS) rate

Other study objectives

Local control patterns (site of 1st progression)

Neuro-cognitive function

Quality of life

+1 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314

36%

Febrile neutropenia

31%

Death NOS

30%

Diarrhea

22%

Pain

21%

Hyperglycemia

16%

Anorexia

16%

Infections and infestations - Other, specify

16%

Alanine aminotransferase increased

14%

Hypokalemia

13%

Nausea

11%

Hyponatremia

10%

Weight loss

Aspartate aminotransferase increased

Mucositis oral

Anemia

Vomiting

Constipation

Dehydration

Hypophosphatemia

Platelet count decreased

Sepsis

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Catheter related infection

Colitis

Abdominal pain

Hypotension

White blood cell decreased

GGT increased

Hypocalcemia

Urinary retention

Hypoalbuminemia

Fever

Typhlitis

Anxiety

Neutrophil count decreased

Urinary tract infection

Peripheral motor neuropathy

Enterocolitis

Lipase increased

Pleural effusion

Serum amylase increased

Skin infection

Epistaxis

Urinary tract obstruction

Blood bilirubin increased

Lymphocyte count decreased

Syncope

Wound infection

Dermatitis radiation

Hypertension

Sinus tachycardia

Edema limbs

Bone pain

Dyspnea

Hematuria

Hypercalcemia

Vulval infection

Upper gastrointestinal hemorrhage

Depressed level of consciousness

Thromboembolic event

Stridor

Allergic reaction

Back pain

Lung infection

Urticaria

Acute kidney injury

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - Other, specify

Pain in extremity

Peripheral sensory neuropathy

Proctitis

Skin ulceration

Apnea

Stoma site infection

Tumor pain

Left ventricular systolic dysfunction

Pancreatitis

Portal hypertension

Rectal hemorrhage

Creatinine increased

Enterocolitis infectious

Hyperkalemia

Investigations - Other, specify

Abdominal distension

Ascites

Heart failure

Vascular disorders - Other, specify

Anal hemorrhage

Vasovagal reaction

Penile pain

Bone marrow hypocellular

Gastrointestinal disorders - Other, specify

Soft tissue infection

Delirium

Tracheitis

Seizure

Hepatobiliary disorders - Other, specify

Esophageal pain

Anal mucositis

Menorrhagia

Sore throat

Anaphylaxis

Fracture

Hydrocephalus

Device related infection

Tooth infection

Gastric ulcer

Sinusitis

Skin and subcutaneous tissue disorders - Other, specify

Pharyngitis

Pyramidal tract syndrome

Anal ulcer

Depression

Ejection fraction decreased

Rash maculo-papular

Pruritus

Myositis

Nail infection

Pain of skin

Pleuritic pain

Pneumonitis

Pneumothorax

Postoperative hemorrhage

Renal and urinary disorders - Other, specify

Respiratory, thoracic and mediastinal disorders - Other, specify

Salivary duct inflammation

Small intestine infection

Alkaline phosphatase increased

Appendicitis

Spinal fracture

Disseminated intravascular coagulation

Ear and labyrinth disorders - Other, specify

Endocrine disorders - Other, specify

Esophageal stenosis

Esophagitis

Gastric hemorrhage

Gum infection

Tumor lysis syndrome

Upper respiratory infection

Hypertriglyceridemia

Hypoxia

Ileus

INR increased

Laryngeal edema

Multi-organ failure

Myelodysplastic syndrome

Oral hemorrhage

Oral pain

Pulmonary edema

Rectal fistula

Rectal pain

Respiratory failure

Bladder spasm

Chest wall pain

Confusion

Congenital, familial and genetic disorders - Other, specify

CPK increased

Dizziness

Encephalopathy

Eye disorders - Other, specify

Generalized muscle weakness

Hoarseness

Hypernatremia

Hypoglycemia

Hypomagnesemia

Insomnia

Irregular menstruation

Irritability

Joint range of motion decreased cervical spine

Kyphosis

Lethargy

Headache

Laryngeal mucositis

Pelvic pain

Esophageal infection

Abdominal infection

Acidosis

Anal fistula

Fall

Fatigue

Gait disturbance

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)

Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

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: Treatment (temozolomide, radiation therapy)Experimental Treatment4 Interventions

Patients receive temozolomide PO daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Temozolomide

2010

Completed Phase 3

~1880