Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to use radiation therapy for treating recurrent glioblastoma, a serious type of brain cancer. The goal is to find out how to safely give radiation to patients whose tumors have returned after they’ve already received radiation treatment. Unfortunately, many patients with recurrent glioblastoma have a poor outlook, so this research aims to improve their treatment options.

To participate, individuals must be at least 18 years old and have been diagnosed with grade 4 glioblastoma that has come back after prior radiation. Participants will undergo various tests to ensure they are healthy enough for the study. They will receive radiation treatment four times a week, with the duration varying between one to three weeks, and will complete health questionnaires throughout the process. Follow-up visits will take place for up to three years after treatment to monitor their progress. This trial is currently recruiting participants and aims to provide valuable information that could help improve care for people with this challenging condition.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
• • Age \>= 18.
• • KPS \>= 70%.
• • Previous tumor irradiation to curative-intent doses.
• • Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.
• * Participants must have adequate organ and marrow function as defined below:
• • Absolute neutrophil count (ANC) \>= 1,000/microL
• • Platelets \>= 100,000/microL
• • Coagulation: Prothrombin time (PT) / Partial thromboplastin time (PTT) within institutional normal range.
• • Total and direct bilirubin \< 2 x institutional upper limit of normal (ULN)
• • Aspartate aminotransferase (AST) \< 2 x institutional ULN
• • Alanine transaminase (ALT) \< 2 x institutional ULN
• • Serum creatinine \< 1.5 mg/dL
• • Serum albumin \>= 0.75 x institutional normal range
• • Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.
• • Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.
• • The ability of a participant to understand and the willingness to sign a written informed consent document.
• EXCLUSION CRITERIA:
• * Recent systemic therapy prior to the initiation of the study therapy as follows:
• • Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
• • Temozolomide within 2 weeks.
• • Cytotoxic chemotherapy within 3 weeks.
• • Any investigational agents within 2 weeks.
• • Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.
• • Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.
• • Requiring radiation therapy within 12 months prior to the initiation of study therapy.
• • History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.
• • Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.
• • Participants with known or suspected radiation sensitivity syndromes.
• • Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.