Chemotherapy and radiation therapy for treating certain types of gliomas
Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)
This study is testing if a combination of a chemotherapy drug and radiation therapy can help people with certain types of brain tumors live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04623931 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of temozolomide combined with radiation therapy in patients with IDH wildtype gliomas, including historically lower grade gliomas and non-histological molecular glioblastomas. The study aims to compare new radiation therapy doses and volumes against standard treatments to improve progression-free survival and overall survival rates. Patients will receive daily temozolomide and radiation therapy over six weeks, followed by additional temozolomide for 12 months. The trial also evaluates neuro-cognitive function, treatment-related symptoms, and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals with IDH wildtype grade II or III gliomas, such as diffuse astrocytoma or anaplastic oligodendroglioma, who have a Karnofsky performance status of 70 or higher.
Not a fit: Patients with IDH mutant gliomas or those with a Karnofsky performance status below 70 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with IDH wildtype gliomas.
How similar studies have performed: Other studies have shown promise with similar chemoradiation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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)
Exclusion Criteria:
* 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)
• New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
* 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Debra N Yeboa — M.D. Anderson Cancer Center
- Study coordinator: Debra N Yeboa
- Email: dnyeboa@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.