Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Description

Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.

Conditions

Astrocytoma, Glioma, Recurrent Glioblastoma

Talk to us

Study Overview

On this page

Study Details

Study overview

Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.

A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Condition
Astrocytoma
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * Women of child-bearing potential (WOCBP) and men 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). Men must not freeze or donate sperm within the same period.
  • * Breastfeeding participants must be willing to discontinue breastfeeding 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.
  • * 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.
  • * History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.
  • * Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in females 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.

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Cancer Institute (NCI),

Peter GK Mathen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

2027-12-31