Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma
Launched by NRG ONCOLOGY · Oct 15, 2021
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether adding a chemotherapy drug called lomustine (Gleostine®) to the usual treatment of temozolomide and radiation therapy can help patients with newly diagnosed glioblastoma, a type of brain cancer. The goal is to see if this combination can shrink or stabilize the tumor more effectively than using temozolomide and radiation therapy alone. Chemotherapy drugs like lomustine and temozolomide work by killing cancer cells or stopping them from growing, while radiation therapy uses high-energy rays to target and destroy the tumor.
To be eligible for this trial, participants must be between 18 and 70 years old, have a confirmed diagnosis of glioblastoma or gliosarcoma, and show specific genetic markers in their tumor. They should also be in reasonably good health overall. Participants can expect to receive treatment and regular check-ups to monitor their progress. It’s important to know that this study is currently recruiting, so interested patients should discuss it with their healthcare provider to see if they qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered)
- • STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H\&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the New York University (NYU) Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be received by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be completed within 10 business days of receipt of tissue. Results will be entered by the central lab directly into Rave. Note: In the event of an additional tumor resection(s), tissue must be received within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis
- • STEP 1 REGISTRATION: Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment; this inclusion is necessary because the treatment in this study may be significantly teratogenic
- • STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
- • STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review
- • STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded
- • Note: Any MGMT result other than methylated would require step 2 registration to be reported as a "central review failure"
- • STEP 2 REGISTRATION: Contrast-enhanced brain MRI performed either after surgery or prior to step 2 registration
- • STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at step 2.)
- • STEP 2 REGISTRATION: History/physical examination within 28 days prior to step 2 registration
- • STEP 2 REGISTRATION: Karnofsky performance status (KPS) \>= 70 within 28 days prior to step 2 registration
- • STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to step 2 registration
- • STEP 2 REGISTRATION: Age 18-70 years
- • STEP 2 REGISTRATION: Hemoglobin \>= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Leukocytes \>= 2,000/mm\^3 (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Absolute neutrophil count \>= 1,500/mm\^3 (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Platelets \>= 100,000/mm\^3 (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Total bilirubin =\< 1.5 x institutional/lab upper limit of normal (ULN) (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 2.5 x ULN (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: Serum creatinine =\< 1.5 x ULN OR creatinine clearance (CrCl) \>= 50 mL/min (if using the Cockcroft-Gault formula) (Within 14 days prior to step 2 registration)
- • STEP 2 REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
- • STEP 2 REGISTRATION: For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV ribonucleic acid \[RNA\]) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
- • STEP 2 REGISTRATION: Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial. Testing is not required for entry into protocol
- • STEP 2 REGISTRATION: Negative serum or urine pregnancy test (in persons of childbearing potential) within 14 days prior to step 2 registration
- • Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Exclusion Criteria:
- • STEP 2 REGISTRATION: Prior therapy for tumor except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery
- • Note: 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent. Prior laser interstitial thermal therapy (LITT) is allowed
- • STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer
- • STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain
- • STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
- • STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields
- • STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants
- • STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine
- • STEP 2 REGISTRATION: History of pulmonary fibrosis
- * STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
- • Ongoing or active infection requiring intravenous (IV) antibiotics, IV antiviral, or IV antifungal treatment
- • Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- • Unstable angina pectoris within 6 months prior to Step 2 registration
- • Uncontrolled cardiac arrhythmia
- • Psychiatric illness/social situations that would limit compliance with study requirements
- • STEP 2 REGISTRATION: No evidence of diffuse leptomeningeal disease that requires whole brain irradiation
About Nrg Oncology
NRG Oncology is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative multi-institutional studies. Comprising a collaborative network of leading academic institutions and community hospitals, NRG Oncology focuses on enhancing patient outcomes by conducting rigorous clinical trials that evaluate new treatment strategies and improve existing therapies. With a commitment to scientific excellence and patient-centered care, the organization plays a vital role in shaping the future of oncology by integrating cutting-edge research with clinical practice, ultimately striving to translate findings into meaningful improvements in cancer care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Carmichael, California, United States
Grand Rapids, Michigan, United States
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Pontiac, Michigan, United States
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Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Johnson Creek, Wisconsin, United States
Irvine, California, United States
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Tawas City, Michigan, United States
Crown Point, Indiana, United States
Golden, Colorado, United States
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Warren, Michigan, United States
Macomb, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Waukee, Iowa, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Patients applied
Trial Officials
Fabio M Iwamoto
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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