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Alkylating agents
Chronotherapy for Glioblastoma
Phase 2
Waitlist Available
Led By Milan Chheda, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed and recurrent high grade gliomas (WHO grades III & IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy
Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 30 months)
Awards & highlights
Study Summary
This trial will study whether the addition of chronotherapy to the standard of care for patients with newly diagnosed GBM will increase overall survival and/or reduce treatment-related toxicity.
Who is the study for?
This trial is for adults over 18 with high-grade gliomas (grades III & IV) or high-risk grade II gliomas, who are scheduled to start monthly high-dose Temozolomide therapy after completing initial treatment. Participants must understand and consent to the study's procedures and have a Karnofsky performance status of at least 60%. Pregnant or breastfeeding individuals, or women who could become pregnant without a recent negative pregnancy test, cannot join.Check my eligibility
What is being tested?
The trial tests if giving the chemotherapy drug Temozolomide at specific times (chronotherapy) can improve outcomes for brain tumor patients by aligning with their body's natural rhythms. The goal is to reduce side effects while increasing the drug's effectiveness against tumors.See study design
What are the potential side effects?
Temozolomide may cause fatigue, nausea, constipation, headache, seizures related to brain tumors' location and size; it might also lower blood cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a high-grade brain tumor and will start high dose temozolomide therapy.
Select...
I am set to receive additional temozolomide therapy after completing my initial treatment with temozolomide and radiation.
Select...
I am 18 years old or older.
Select...
I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 30 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 30 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of response
Feasibility of patient treatment compliance as measured by at least 80% compliance with assigned administration time
Secondary outcome measures
Comparison of the level of sleep disruption in sleep-wake cycles of participants receiving temozolomide in the morning versus participants receiving temozolomide in the evening
Number of patients experiencing grade 3 or 4 lymphopenia, thrombocytopenia, neutropenia and anemia in each group as measured by standard blood draws
Overall survival
+2 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%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
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
2Treatment groups
Experimental Treatment
Group I: Arm 2: Temozolomide eveningExperimental Treatment3 Interventions
Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).
FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment
Group II: Arm 1: Temozolomide morningExperimental Treatment3 Interventions
Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).
FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,667 Total Patients Enrolled
17 Trials studying Glioblastoma
579 Patients Enrolled for Glioblastoma
Milan Chheda, M.D.Principal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
158 Total Patients Enrolled
2 Trials studying Glioblastoma
88 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a high-grade brain tumor and will start high dose temozolomide therapy.I am set to receive additional temozolomide therapy after completing my initial treatment with temozolomide and radiation.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.I can care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Temozolomide morning
- Group 2: Arm 2: Temozolomide evening
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.
Is this the inaugural research effort of its type?
"Temozolomide has been studied since 2002, when a trial sponsored by Schering-Plough involved 60 participants. This research enabled the drug to receive Phase 2 approval, and as of today there are 207 active studies for Temozolomide in 36 countries across 935 cities."
Answered by AI
What is the participant pool of this research endeavor?
"The recruitment period for this trial has concluded. This scientific experiment was initially published on the 11th of August 2016, and had its most recent edit on October 5th 2022. Alternately, there are currently 705 glioma studies that are actively enrolling along with 207 trials focused on Temozolomide which still welcome new participants."
Answered by AI
In which clinical contexts is Temozolomide typically deployed?
"As nitrosourea therapy, Temozolomide is a popular choice. Other health issues tackled by this medication include advanced directives, refractory mycosis fungoides, and treatment-resistant neuroblastoma."
Answered by AI
What other investigations have been conducted regarding Temozolomide?
"Currently, Temozolomide is being investigated in 207 clinical trials. Of those studies, 24 of them are Phase 3 and located mainly in Seoul's Songpa district. However, the research for this drug spans 4752 separate sites across the world."
Answered by AI
Are there any openings for participants in this clinical experiment?
"This medical trial is no longer open for recruiting; it was first posted on August 11th 2016 and most recently revised on October 5th 2022. Nevertheless, there are still 705 trials concerning glioma that require participants and an additional 207 studies involving temozolomide currently enrolling patients."
Answered by AI
Has Temozolomide been granted regulatory approval by the US Food and Drug Administration?
"Based on available evidence, our team has assigned Temozolomide a safety score of 2; while some data exists to suggest the drug is safe there is no proof yet that it will be effective."
Answered by AI
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