Bicalutamide + Re-irradiation for Brain Cancer

Overseen By Taylor Johnson, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Nebraska

Must be taking: Bicalutamide

Must not be taking: Androgen deprivation therapy, Temozolomide

Disqualifiers: AIDS, Severe heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for individuals with high-grade glioma, a severe form of brain cancer that has returned or worsened after previous treatment. The trial aims to determine the safety of taking bicalutamide (a type of hormone therapy) alongside radiation therapy to the brain. Participants will take bicalutamide daily for six months, receive radiation, and document their experiences and any side effects. This trial suits those with a past diagnosis of high-grade glioma whose cancer has returned or progressed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it does mention that you cannot be on certain medications like androgen deprivation therapy or temozolomide. If you are on bevacizumab, it must be stopped at least two weeks before starting the trial treatments.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that bicalutamide, when used alone, has been studied for safety in other conditions. It is generally well-tolerated, with common side effects including hot flashes, breast tenderness, and nausea.

The safety of bicalutamide combined with brain re-irradiation is still under investigation. This trial is in an early stage, focusing primarily on safety and determining the correct dose. Researchers begin with a low dose and gradually increase it to assess how much participants can safely tolerate without serious side effects.

The trial aims to determine if combining bicalutamide with radiation treatment for brain cancer is safe. Previous studies with bicalutamide alone provide some confidence about its safety, but its use with brain radiation is new. This trial seeks to evaluate the combination's effectiveness and patient tolerance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of bicalutamide and re-irradiation for brain cancer because it offers a novel approach to tackling this tough condition. Unlike standard treatments that mainly focus on chemotherapy or initial radiation, this approach uses bicalutamide, an androgen receptor inhibitor typically used in prostate cancer, to potentially enhance the effectiveness of re-irradiation. By targeting androgen receptors, this treatment aims to slow tumor growth and improve outcomes for patients who have limited options after initial therapies. This strategy could open new doors for treating brain cancer, especially for those who have not responded to conventional treatments.

What evidence suggests that this treatment might be an effective treatment for high-grade glioma?

In this trial, participants will receive bicalutamide combined with repeated radiation treatment to explore its potential in treating high-grade glioma, a type of brain cancer. Research has shown that bicalutamide blocks certain hormones that may promote cancer growth. Although specific data on bicalutamide for brain cancer is limited, similar drugs like enzalutamide have demonstrated significant tumor reduction in other studies. Repeated radiation has also helped control tumors more effectively, with past studies noting longer survival times for patients. Overall, these early signs suggest possible benefits, but further research is needed. ^{1 2 3 6 7}

Who Is on the Research Team?

Chi Zhang, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for people with high-grade glioma, a type of brain cancer, that has returned or worsened despite previous treatment. Eligible participants may have had surgery recently but must be recovered. They should have evidence of tumor progression and can't participate if they cannot undergo necessary imaging or meet certain medication timelines.

Inclusion Criteria

I don't need to have remaining tumor after surgery to join.

I have been diagnosed with a high-grade brain tumor.

I can't have an MR scan due to a device I have, but I can get a CT scan instead.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take bicalutamide daily and receive 10 fractions of brain re-irradiation

6 months

Clinic visits every 8 weeks for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 26 months

Long-term Follow-up

Participants' quality of survival is assessed using cognitive and performance scales

Up to 44 months

What Are the Treatments Tested in This Trial?

Interventions

• Bicalutamide
• Intensity-modulated radiation therapy (IMRT)

Trial Overview The study tests the safety of taking bicalutamide daily for six months while receiving brain radiation therapy (IMRT). Participants will keep a diary to note when they take the medicine and any side effects, with clinic visits every eight weeks for checkups and tests.

How Is the Trial Designed?

Group I: Bicalutamide with brain re-irradiation Experimental Treatment 2 Interventions

Participants 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.

Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in United States as Casodex for:

• Metastatic prostate cancer

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

Cisplatin combined with other agents like vinblastine or etoposide shows promise as an effective pre-radiotherapy treatment for locally advanced non-small cell lung cancer (NSCLC), but optimal scheduling is still being researched.

In a study of 170 patients, concurrent chemotherapy with carboplatin and radiation led to increased toxicity, including significantly higher rates of neutropenia and thrombocytopenia, indicating that while this approach may improve treatment efficacy, it also raises safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduling of chemotherapy and radiotherapy in locally advanced non-small cell lung cancer. Bishop, JF.[2019]

Combined treatment of radiotherapy with cisplatin and etoposide has shown significant improvements in local control and survival rates for patients with locally advanced non-small cell lung cancer (NSCLC), with median survival rates reported between 15-18 months and 2-year survival rates around 35-40%.

Recent advancements in radiation technology and the use of third-generation chemotherapy drugs have led to promising results, including median survival exceeding 20 months, although careful management of treatment to minimize toxicity, particularly esophageal toxicity, remains crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy and chemotherapy in locally advanced non-small cell lung cancer: preclinical and early clinical data. Reboul, FL.[2019]

Current treatments for brain tumors are often inadequate, leading to ongoing research into the use of concurrent chemotherapy and radiotherapy to improve patient outcomes.

Trials are exploring new agents that can effectively cross the blood-brain barrier and minimize overlapping toxicities, which may enhance the safety and efficacy of combined therapies for brain tumor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent chemotherapy and radiotherapy in patients with brain tumors. Glantz, MJ., Kim, L., Choy, H., et al.[2005]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-01292

Bicalutamide with Brain Re-Irradiation for the Treatment of ... This phase I trial tests the safety, side effects and best dose of bicalutamide with repeat brain radiation treatment (re-irradiation) in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10779261/

Intracranial Assessment of Androgen Receptor Antagonists ... Oral enzalutamide at 20 mg/kg reduces subcutaneous human glioblastoma xenografts by 72% (p = 0.0027). We aimed to further investigate the ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-bicalutamide-with-brain-re-irradiation-to-treat-recurrent-progressive-high-grade-glioma

A Study of Bicalutamide With Brain Re-irradiation to Treat ... This study is for people who have previously received treatment for brain cancer, but the cancer has come back or gotten worse after treatment.

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/recurrent-cancer

Recurrent Cancer Clinical Trials The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors. The BEACON Study (Breast Cancer Outcomes With ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589175/

Reirradiation versus systemic therapy versus combination ... Retrospective data suggests that reRT is safe and provides improved local control [8], with a median reported OS of 7.5–16 months [6] and an OS- ...

6. nebraskamed.com nebraskamed.com/clinical-trials/cancer-clinical-trials/onc608-24

Clinical Trial Details | Nebraska Medicine Omaha, NE Primary objective: 1. To evaluate the safety when combining partial brain re-irradiation with bicalutamide. Side effects of the study drug combined with RT will ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/020498s028lbl.pdf

CASODEX (bicalutamide) tablet, for oral use Safety Data from Clinical Studies using CASODEX 150 mg. CASODEX 150 mg is not approved for use either alone or with other treatments. Two identical multi ...