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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My brain tumor is a high-grade glioma or glioblastoma without IDH mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Overall survival (OS) rate
Other outcome measures
Local control patterns (site of 1st progression)
Neuro-cognitive function
Quality of life
+1 moreSide effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
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
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Syncope
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
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
~1930
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,977 Previous Clinical Trials
1,789,508 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,836 Total Patients Enrolled
Debra N YeboaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lining of my brain and spinal cord.I must have an MRI with contrast for my radiation therapy plan.I was hospitalized for heart failure that affects my daily activities within the last year.My diagnosis is either gliosarcoma (grade IV) or pilocytic astrocytoma (grade I).I am currently on IV antibiotics for a bacterial or fungal infection.I have a serious heart rhythm problem that is not well-controlled.I do not have a severe lung condition that requires hospital care right now.I have severe kidney disease requiring dialysis.You have certain conditions like lupus or scleroderma that may increase your risk of side effects from radiation treatment, according to your doctor's opinion.My brain tumor is a type of glioma that is not IDH mutated.I haven't had serious wounds, ulcers, fractures, or major surgeries in the last 28 days.My hemoglobin level is at least 10.0 g/dl, possibly after a transfusion.I have been cancer-free for at least 3 years, except for non-dangerous skin cancers.I do not have liver problems causing jaundice or blood clotting issues.I have had or will have detailed MRI scans for treatment planning.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I had a major heart attack in the last 6 months, confirmed by an EKG.My brain tumor is a high-grade glioma or glioblastoma without IDH mutation.You have a weakened immune system from a serious health condition.I have had chemotherapy or radiotherapy for a brain tumor before.You are not able to have an MRI scan with and without a special dye.You have a serious health condition that is currently causing you a lot of problems.I have had radiation therapy to my head or neck before.I can care for myself and perform normal activities with minimal assistance.My brain cancer is present in multiple areas.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (temozolomide, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for this clinical trial?
"Affirmative. Clinicaltrials.gov exhibits that this clinical trial, initially posted on January 30th 2020 is actively recruiting participants. A total of 40 individuals need to be enlisted from a single medical facility for the study's continuation."
Answered by AI
What is the maximum capacity of participants for this medical trial?
"Affirmative. The information stored on clinicaltrials.gov indicates that this medical trial, which was originally published in January 2020, is actively enrolling patients. A total of 40 participants are required at a single research site."
Answered by AI
In what medical setting is Temozolomide usually prescribed?
"Temozolomide is typically prescribed to treat nitrosourea therapy, but it also has applications in treating advanced directives, refractory mycosis fungoides, as well as refractory neuroblastoma."
Answered by AI
Has Temozolomide been researched in any other experiments?
"As of now, 207 clinical trials have been launched to study Temozolomide with 24 in the third phase. The majority are located near Seoul Songpa, but there are 4752 research centers running studies around this drug."
Answered by AI
Does Temozolomide carry any adverse effects for individuals?
"The safety of Temozolomide was evaluated as a 2 on our Power scale, since the trial is only in Stage 2 and has evidence that bolsters its safety profile but no efficacy data."
Answered by AI
Are any of the findings from this research groundbreaking?
"Temozolomide has been a subject of medical research since 2002, starting with an initial study conducted by Schering-Plough. This 60 patient trial granted the drug Phase 2 approval and triggered many other clinical trials; at present there are 207 studies involving this medication in 36 nations over 935 cities."
Answered by AI
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