Re-irradiation for recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine a safe schedule for re-irradiation in patients with recurrent glioblastoma (GBM) after initial radiation treatment. Participants aged 18 and older with grade 4 GBM will undergo screening, physical exams, and imaging scans to identify the tumor's exact location. The study will utilize a '3 plus 3' design to evaluate different doses of radiation therapy, focusing on maximizing the tolerated dosage while minimizing risks to surrounding healthy tissue. The goal is to improve treatment options for patients whose tumors have returned after previous therapies.

Why it matters

Who can join: the full rules

* 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
* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Peter GK Mathen, M.D. — National Cancer Institute (NCI)
• Study coordinator: Rukayat O Salau
• Email: rukayat.salau@nih.gov
• Phone: (240) 858-3712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.