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New treatment option for Anaplastic Astrocytoma, IDH-Wildtype
Official title Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
ClinicalTrials.gov ID: NCT04623931
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anaplastic astrocytoma, idh-wildtype.
Also referred to as CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic...
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.