A Phase 1/2 interventional study of Hypofractionated radiotherapy and Temozolomide in Glioblastoma, sponsored by University of Louisville. Active, not recruiting at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by University of Louisville · Phase 1/2, Interventional, and Treatment
In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.
1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.
This study's enrollment of 18 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Louisville is the lead sponsor of 290 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
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Patients must have normal organ and marrow function
Exclusion Criteria:
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
Radiation: Hypofractionated radiotherapy · Drug: Temozolomide
Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.
During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.
Also known as: Brand name Temodar
Number of patients who stop treatment due to Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above toxicities..
If \< 4 out of 10 patients in the initial analysis stop treatment due to toxicity it can proceed to phase II.
Time frame: baseline, 14-28 days post-surgery, 4 weeks post chemo-radiation therapy, 1, 2, 3, 4, 5, and 6 months post Radiation Therapy
Overall survival
Survival status will be collected after completion of chemo-radiation at minimum every 3 months for up to 12 months, then every 6 months until date of death.
Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.
Estimate progression-free survival (PFS)
Survival/Documentation of progressive disease status will be collected every 3 months post chemo-radiation up to 12 months, then every 6 months until death, or from the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression.
Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.
Tolerability (feasibility) of hypo-fractionated radiaton therapy and Temozolomide
Quality of life will be measured by Fact-BR assessment.
Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.
Explore association of Overall Survival (OS) and Progression Free Survival (PFS) with 06-methylguanine-DNA methyltransferase gene (MGMT) methylation status
Survival/Documentation of progressive disease status will be collected 4-weeks post chemo-radiation therapy then every 3 months up to 12 months, then every 6 months until death, from either the date of disease progression, the date of study discontinuation (e.g. toxicity, PI decision), or from the date of the last dose of study drug (concomitant or adjuvant) if no disease progression.
Time frame: From date of intervention until the date of first documented disease progression or death, the date of study discontinuation (e.g. toxicity, PI decision) or death from any cause, whichever is first, assessed up to 100 months.
Explore changes in quality of life (QOL)
To explore changes in QOL measured by Functional Assessment of Cancer Therapy (FACT-BR) and its predictors.
Time frame: 14-28 days after surgery then within 4 weeks from end of chemotherapy-radiation then 1,4, and 6 months post initiation of adjuvant treatment
The record gives a start of Sep 2014, a primary completion of May 2025 and a completion of May 2025. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Temozolomide