RECRUITING

Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas

Conditions

Anaplastic Astrocytoma, IDH-Wildtype Anaplastic Oligoastrocytoma Anaplastic Oligodendroglioma Diffuse Astrocytoma, IDH-Wildtype Glioblastoma Oligoastrocytoma Oligodendroglioma WHO Grade II Glioma WHO Grade III Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.

Official Title

Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)

Quick Facts

Study Start:2020-01-30

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04623931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma * IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma \[GBM\]) * History \& physical exam, and Karnofsky performance status (KFS) of \>= 70 within 30 days prior to enrollment * Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning * Thin-slice (\< 1.5 mm) three-dimensional (3D) T1 pre and post contrast and axial T2/fluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain. * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration) * Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration) * Hemoglobin \>= 10.0 g/dl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable) * Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 60 days prior to registration) * Blood urea nitrogen (BUN) \< 30 mg/dl (within 60 days prior to registration) * Serum creatinine \< 1.5 mg/dl (within 60 days prior to registration)	* Definitive clinical or radiologic evidence of metastatic disease; if applicable * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible) * Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist * Prior chemotherapy or radiotherapy for any brain tumor * Histologic diagnosis of gliosarcoma World Health Organization (WHO grade IV) or pilocytic astrocytoma (WHO grade I) * Multicentric glioblastoma * Leptomeningeal disease * Inability to undergo MRI with and without contrast * Severe, active co-morbidity defined as follows: * Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment * Transmural myocardial infarction within the last 6 months prior to registration. Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue) * Serious and inadequately controlled arrhythmia at step 2 registration * Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed * Any other severe immunocompromised condition * Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity * End-stage renal disease (i.e., on dialysis or dialysis has been recommended) * Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy

Inclusion Criteria

Exclusion Criteria

* Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
* IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma \[GBM\])
* History \& physical exam, and Karnofsky performance status (KFS) of \>= 70 within 30 days prior to enrollment
* Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning
* Thin-slice (\< 1.5 mm) three-dimensional (3D) T1 pre and post contrast and axial T2/fluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain.
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration)
* Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration)
* Hemoglobin \>= 10.0 g/dl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable)
* Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 60 days prior to registration)
* Blood urea nitrogen (BUN) \< 30 mg/dl (within 60 days prior to registration)
* Serum creatinine \< 1.5 mg/dl (within 60 days prior to registration)

* Definitive clinical or radiologic evidence of metastatic disease; if applicable
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (For example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
* Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
* Prior chemotherapy or radiotherapy for any brain tumor
* Histologic diagnosis of gliosarcoma World Health Organization (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
* Multicentric glioblastoma
* Leptomeningeal disease
* Inability to undergo MRI with and without contrast
* Severe, active co-morbidity defined as follows:
* Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment
* Transmural myocardial infarction within the last 6 months prior to registration. Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue)
* Serious and inadequately controlled arrhythmia at step 2 registration
* Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* Human immunodeficiency virus (HIV) positive with CD4 count \< 200 cells/microliter. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is because the treatments involved in this protocol may be significantly immunosuppressive with potentially fatal outcomes in patients already immunosuppressed
* Any other severe immunocompromised condition
* Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
* Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy

Contacts and Locations

Study Contact

Debra N Yeboa

CONTACT

713-563-2300

dnyeboa@mdanderson.org

Principal Investigator

Debra N Yeboa

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Debra N Yeboa, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-01-30

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Anaplastic Astrocytoma, IDH-Wildtype
Anaplastic Oligoastrocytoma
Anaplastic Oligodendroglioma
Diffuse Astrocytoma, IDH-Wildtype
Glioblastoma
Oligoastrocytoma
Oligodendroglioma
WHO Grade II Glioma
WHO Grade III Glioma