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Recurrent GlioblastomaPhase 1NCT06501911

A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma

A Phase 1 study testing Bicalutamide and Intensity-modulated radiation therapy (IMRT) in people with Recurrent Glioblastoma and Recurrent High-grade Glioma, run by University of Nebraska at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this study is to learn about a type of brain cancer called high-grade glioma. This study is for people who have previously received treatment for brain cancer, but the cancer has come back or gotten worse after treatment. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Bicalutamide and Intensity-modulated radiation therapy (IMRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
8 Apr 2025to 17 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically proven diagnosis of relapsed/refractory high-grade glioma (HGG) including glioblastoma or variants (gliosarcoma, giant cell glioblastoma etc), World Health Organization (WHO) grade IV, or anaplastic astrocytoma, or anaplastic oligodendroglioma, WHO grade III. Participants will be eligible if the original histology was lower-grade glioma and a subsequent diagnosis of HGG (secondary HGG) is made.
  • Participants who did not have surgery for their HGG within 5 weeks prior to enrollment must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan (or CT scan for participants with non-compatible devices). Imaging completed prior to enrollment will be acceptable for eligibility purposes if completed within 4 weeks prior to enrollment. If imaging was not completed within 4 weeks prior to enrollment then imaging must be completed within 14 days after enrollment and prior to the start of RT.
  • Participants unable to undergo magnetic resonance (MR) imaging because of non-compatible devices can be enrolled provided CT scans are obtained and are of sufficient quality. Participants without non-compatible devices may not use CT scans performed to meet this requirement.
  • Participants must have passed an interval of 6 months or greater between completion of prior radiotherapy and enrollment. If participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
  • New areas of tumor outside the original radiotherapy fields as determined by the investigator
  • Histologic confirmation of tumor through biopsy or resection
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  • Nuclear medicine imaging, MR spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of previous radiotherapy and registration
  • Prior history of standard dose central nervous system (CNS) radiation of 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower doses.
  • Participants must have recovered from the toxic effects of prior chemotherapy, and there must be a minimum time of 14 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
  • 14 days from administration of vincristine
  • 42 days from administration of nitrosoureas
  • 21 days from administration of procarbazine
  • Participants having undergone recent resection of their glioblastoma (within 5 weeks prior to enrollment) must have recovered from the effects of surgery. For CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to enrollment.
  • Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study.
  • History/physical examination, including neurologic examination, within 14 days prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2 within 14 days prior to enrollment
  • Age ≥ 19 (Age of majority in Nebraska)
  • Complete blood count (CBC)/differential obtained within 14 days of enrollment, with adequate bone marrow function. Adequate bone marrow reserve as follows:
  • o Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 Platelets ≥ 75,000 cells/mm3 Hemoglobin ≥ 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable.) Note: If a CBC w/differential was not obtained prior to enrollment it must be completed within 14 days of enrollment and prior to the start of bicalutamide.
  • Acceptable liver (total bilirubin < 2.0 mg/dL, and glutamic-oxaloacetic transaminase (SGOT) or Aspartate Transferase (AST) < 2.5 times the upper limit of normal) and renal function [serum creatinine < 1.8 mg/dL and calculated creatinine clearance > 30 ml/min (Cockroft-Gault)] within 14 days of enrollment. Note: If labs were not completed prior to enrollment they must be completed within 14 days of enrollment and prior to the start of bicalutamide.
  • Urine protein: creatinine (UPC) ratio < 1.0 OR urine dipstick for proteinuria ≤ 2+ completed within 14 days of enrollment. If not completed prior to enrollment it must be completed within 14 days and prior to the start of bicalutamide. Note: Participants discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is <1.0 to be eligible. If the UPC ratio is ≥ 1.0 then the Participants will undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible. If a 24-hour urine collection is necessary it must be completed within 14 days of enrollment and prior to the start of bicalutamide. Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas:
  • [urine protein]/[urine creatinine]: if both protein and creatinine are reported in mg/dL
  • [(urine protein) x0.088]/[urine creatinine]: if urine creatinine is reported in mmol/L
  • Participants must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 7 days of enrollment and prior to the start of RT. Effective contraception (men and women), i.e., effective physical barrier methods, must be used in subjects of child-bearing potential while on study treatment and for 6 months after. Oral contraceptives are not allowed as a form of contraception due to potential interference of testosterone levels.
  • Participants on full-dose anticoagulants [e.g., warfarin or low molecular weight heparin (LMW) heparin] must meet both of the following criteria:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range international normalised ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 14 days of enrollment and prior to the start of bicalutamide
  • Participants must be able to provide study-specific informed consent prior to study entry.

Who cannot join

  • Infratentorial, or diffuse leptomeningeal evidence of recurrent disease. If focal leptomeningeal disease (per treating physician's determination of being "focal"), participants can be considered eligible.
  • Ongoing therapy with any androgen deprivation therapy (ADT) such as leuprolide acetate, degarelix, bicalutamide, flutamide, enzalutamide, apalutamide, abiraterone acetate, darolutamide or others per principal investigator's determination. If ADT has been stopped prior to the enrollment, at least 6 months of ADT-free time is required for eligibility.
  • Prior allergic reaction to the drug bicalutamide 3.2.4 Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, prostate, or cervix are all permissible).
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration.
  • Congestive heart failure (NYHA functional capacity class II or greater).
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  • Transmural myocardial infarction within the last 6 months prior to registration.
  • History of stroke or transient ischemic attack within 6 months prior to registration.
  • Ongoing arrhythmias of Grade >2 [CTCAE, version 5.0]; Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
  • Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past 6 months.
  • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
  • Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 3.2.6 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
  • Known Acquired Immune Deficiency Syndrome (AIDS) diagnosis based upon current Centers for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude participants with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Immuno-compromised participants with transplant in history are excluded.
  • Uncontrolled seizures or controlled seizure in the past 3 months but requires more than levetiracetam 500mg orally twice a day, i.e., with higher dose of levetiracetam or additional antiepileptics (excluding steroids).
  • Any prior history of hypertensive crisis or hypertensive encephalopathy. 3.2.12 History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to enrollment 3.2.13 Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
  • Participants who are on testosterone supplement due to medical reasons that cannot be safely discontinued.
  • Participants who are on temozolomide treatment and have no plan to stop temozolomide prior to consent or who will be offered temozolomide concurrently with re-RT. Subjects on bevacizumab whose bevacizumab cannot be stopped are not eligible and bevacizumab is not allowed for concurrent use with bicalutamide and re-RT but is allowed after at least two weeks (washout time) after discontinuation of re-RT and bicalutamide.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Phase I Dose Escalation Study on Bicalutamide, an Androgen Receptor Antagonist, as a Radiosensitizer Combining With Brain Re-irradiation to Treat Recurrent/Progressive Glioblastoma/High Grade Glioma

The goal of this study is to learn about a type of brain cancer called high-grade glioma. This study is for people who have previously received treatment for brain cancer, but the cancer has come back or gotten worse after treatment. The main question this study aims to answer is: is it safe for participants to take bicalutamide while receiving brain radiation treatment?

Participants will:

  • Take bicalutamide every day for 6 months
  • Receive radiation treatment to the brain
  • Keep a diary of the when they take the bicalutamide and any side effects experienced
  • Visit the clinic once every 8 weeks for checkups and tests
Read the detailed description

Participants will be enrolled according to a standard cohort 3+3 dose-escalation/de-escalation study design at a starting dose of 150 mg of bicalutamide. Up to six (6) subjects will be enrolled to a given dose level until the Maximum Tolerated Dose (MTD) is reached, or until a maximum dose of 600 mg is reached. The MTD is defined as the dose below which two (2) or more of six (6) subjects experience a dose limiting toxicity (DLT). If the starting dose exceeds the MTD, the dose will be decreased until a minimum dose of 25 mg is reached.

Primary Objective:

  1. To evaluate the safety when combining partial brain re-irradiation with bicalutamide. Side effects of the study drug combined with radiation therapy (RT) will be assessed per CTCAE 5.0.

Secondary Objectives:

  1. To estimate the rate of objective response rate (ORR) in subjects with treatment. Response Assessment in Neuro-Oncology (RANO) criteria will be used to estimate ORR.
  2. To estimate the 6-month progression-free survival rate.
  3. To evaluate the impact of combining bicalutamide with brain re-irradiation on quality of survival, as measured by changes to scores on the Montreal Cognitive Assessment (MoCA) and Karnofsky performance status.
Being tested
Bicalutamide, Intensity-modulated radiation therapy (IMRT)
Keywords
Progressive high grade glioma
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BicalutamideDrug

    Also called Casodex

    Participants will receive daily oral bicalutamide for six (6) months. The dose will be determined by the cohort to which the participant is enrolled as well as the toxicities experienced by previously enrolled cohorts.

  • Intensity-modulated radiation therapy (IMRT)Radiation

    Also called Three-Dimensional Conformal Radiation Therapy (3D-CRT)

    Participants will receive 35 Gy delivered in 10 fractions, administered once daily on weekdays.

Study groups in NCT06501911
Study groupRoleWhat they receive
Bicalutamide with brain re-irradiationExperimentalParticipants will take oral bicalutamide daily for six (6) months at a starting dose of 150 mg daily. Participants will be enrolled in cohorts of six (6) participants. The dose will be incrementally adjusted based on dose limiting toxicities seen in the previously enrolled cohort until the Maximum Tolerated Dose (MTD) is reached. The MTD is defined as the dose level below the dose at which at least two (2) of six (6) participants experienced a dose limiting toxicity. Participants will also receive 10 fractions of brain re-irradiation beginning one week after the start of bicalutamide treatment.
Receives: Drug: Bicalutamide; Radiation: Intensity-modulated radiation therapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of adverse events (AEs) in participants receiving study treatment (combining partial brain re-irradiation with bicalutamide)

    The incidence of adverse events (AEs) will be described for each dose level cohort as well as the two highest dose levels combined. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on a scale ranging from 1 to 5, with higher numbers indicating a higher severity grade.

    Measured: Up to 26 months

  2. The incidence of serious adverse events (SAEs) in participants receiving study treatment (combining partial brain re-irradiation with bicalutamide)

    The incidence of serious adverse events (SAEs) will be described for each dose level cohort as well as the two highest dose levels combined. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on a scale ranging from 1 to 5, with higher numbers indicating a higher severity grade.

    Measured: Up to 26 months

Secondary outcomes (4)

  1. Rate of objective response (ORR) in participants receiving treatment

    The rate of objective response (ORR) in subjects receiving treatment will be assessed using Response Assessment in Neuro-Oncology (RANO) Criteria. MRI and clinical features are used to classify response as one of four categories that range from complete response to disease progression.

    Measured: Up to 44 months

  2. Six-month Progression-free Survival Rate

    Progression-free survival (PFS) will be estimated using the Kaplan-Meier method which estimates event probability occurring at a specific time point among subject who have not already experienced that event. PFS is defined as the time from the date of consent to disease progression or death.

    Measured: Up to 26 months

  3. The impact of study treatment on quality of survival (Montreal Cognitive Assessment)

    To evaluate the impact of combining bicalutamide with brain re-irradiation on the quality of survival, score changes on the Montreal Cognitive Assessment (MoCA) will be measured at protocol-specified time points throughout the study. Maximum score on the assessment is 30 (scores of 30 to 26 indicate no impairment, 25 to 18 mild cognitive impairment, 17 to 10 moderate cognitive impairment, less than 10 severe cognitive impairment.

    Measured: Up to 44 months

  4. The impact of study treatment on quality of survival (Karnofsky Performance Scale)

    To evaluate the impact of combining bicalutamide with brain re-irradiation on the quality of survival, scores changes on the Karnofsky Performance Scale will be measured. This scale ranges from 0 to 100: 100 indicates normal health and survival decreases with decreasing scores.

    Measured: Up to 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start8 Apr 2025
  3. Primary completion17 Jul 2025
  4. Study completion17 Jul 2025

Why it stopped: PI leaving institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501911
Sponsor's protocol ID
0608-24-FB
Status last verified
Mar 2025
First submitted
5 Jul 2024
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bicalutamide and Intensity-modulated radiation therapy (IMRT) in people with Recurrent Glioblastoma and Recurrent High-grade Glioma, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of adverse events (AEs) in participants receiving study treatment (combining partial brain re-irradiation with bicalutamide) (time frame: Up to 26 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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