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Alkylating agents

Lomustine + Standard Therapy for Glioblastoma

Phase 3
Recruiting
Led By Fabio M Iwamoto
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologically proven diagnosis of glioblastoma confirmed by central pathology review
IDH mutation testing with no mutation found
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is comparing the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in treating newly diagnosed MGMT methylated glioblastoma.

Who is the study for?
Adults aged 18-70 with newly diagnosed MGMT methylated glioblastoma, without prior treatments except surgery. Participants must have proper liver and kidney function, no known IDH mutation or other cancers in the last two years, and be willing to use effective contraception. Excludes pregnant/nursing individuals, those with metastatic disease outside the brain, certain heart conditions, uncontrolled illnesses or infections.Check my eligibility
What is being tested?
This phase III trial is testing if adding Lomustine to the standard treatment of Temozolomide and radiation therapy improves outcomes for patients with specific brain cancer (glioblastoma). Patients are compared between receiving this combination versus just Temozolomide and radiation.See study design
What are the potential side effects?
Lomustine can cause fatigue, loss of appetite, nausea, vomiting; it may also lower blood cell counts increasing infection risk. Temozolomide has similar effects including headaches and constipation. Radiation therapy might lead to hair loss at treated site and skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My glioblastoma diagnosis has been confirmed by a specialized review.
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My cancer does not have an IDH mutation.
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I am able to care for myself but may not be able to do active work.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I am between 18 and 70 years old.
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I had hepatitis C but am now cured or have no detectable virus.
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My cancer does not have an IDH mutation.
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I have chronic hepatitis B but it's under control with medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Incidence of Adverse Events
Patient reported outcomes for Brain Tumors
Progression Free Survival (PFS)
Other outcome measures
Absolute lymphocyte counts

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARM II (radiation therapy, temozolomide, lomustine)Experimental Treatment5 Interventions
Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (radiation therapy, temozolomide)Active Control4 Interventions
Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
2008
Completed Phase 3
~1540
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,546 Total Patients Enrolled
13 Trials studying Glioblastoma
3,822 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,767 Total Patients Enrolled
322 Trials studying Glioblastoma
22,809 Patients Enrolled for Glioblastoma
Fabio M IwamotoPrincipal InvestigatorNRG Oncology

Media Library

Lomustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05095376 — Phase 3
Glioblastoma Research Study Groups: Arm I (radiation therapy, temozolomide), ARM II (radiation therapy, temozolomide, lomustine)
Glioblastoma Clinical Trial 2023: Lomustine Highlights & Side Effects. Trial Name: NCT05095376 — Phase 3
Lomustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05095376 — Phase 3

Frequently Asked Questions

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

Are there certain inclusion criteria for this research study?

"This study is recruiting 306 individuals that have glioblastoma and are between 18-70 years old."

Answered by AI

How many volunteers are participating in this experiment?

"In order to run this clinical trial, 306 patients that meet the given inclusion criteria are needed. These individuals can participate at one of many different sites including Fairview Southdale Hospital or Aurora Saint Luke's Medical Center."

Answered by AI

How does this Quality-of-Life Assessment compare to others in its field?

"The Quality-of-Life Assessment was first trialed in 2002 at Memorial Sloan Kettering Cancer Center. In the 18 years since, there have been 542 completed studies on this topic. There are currently 234 live trials, many of which based out of Edina, Minnesota."

Answered by AI

Does this trial seek octogenarian participants?

"This trial's age requirements for participation are between 18 and 70 years old."

Answered by AI

Is Quality-of-Life Assessment a risk-free way to improve patient care?

"There is prior clinical data supporting Quality-of-Life Assessment's safety, so it received a score of 3."

Answered by AI

Is this a unique clinical trial?

"There have been a total of 234 ongoing trials for Quality-of-Life Assessment spread out over 969 cities and 39 countries. The first such trial was sponsored by Schering-Plough in 2002. That study completed its Phase 2 drug approval stage with 60 patients. In the almost two decades since that initial study, 542 similar trials have been completed."

Answered by AI

What issues does Quality-of-Life Assessment commonly address?

"Quality-of-Life Assessments are commonly used to establish patient directives in advance of treatment. However, they can also be useful for tracking the progression of hodgkin disease and measuring the efficacy of nitrosourea treatments."

Answered by AI

In how many different medical clinics is this trial being run today?

"This study is currently looking for participants at 100 clinical trial sites. While the primary locations are in Edina, Milwaukee and Kansas City, there are also many other centres located throughout America. To cut down on participant burden, it is recommended that you select a site near to your home."

Answered by AI

Are investigators looking for more participants at this time?

"Yes, this is accurate. The clinicaltrials.gov website contains information indicating that the trial is currently recruiting patients. This study was originally posted on 11/29/2021 and was last updated on 8/11/2022. They are looking to recruit 306 patients from 100 different sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Kaiser Permanente Oakland-Broadway
Kaiser Permanente-San Francisco
Kaiser Permanente-Vallejo
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
2021. "Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05095376.
All > Glioblastoma Albuquerque
~148 spots leftby Aug 2026
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