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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 the combination of Bicalutamide and re-irradiation for brain cancer safe for humans?

The safety data for Bicalutamide specifically in combination with re-irradiation for brain cancer is not available in the provided research. However, related treatments involving cisplatin and radiation have shown potential side effects such as retinal and neurological toxicity, as well as renal and auditory toxicities in other studies. ^{1 2 3 4 5}

What makes the drug Bicalutamide unique for treating brain cancer?

Bicalutamide is unique for brain cancer treatment because it is primarily used as an anti-androgen drug for prostate cancer, and its use in combination with re-irradiation for brain cancer is novel, as there are no standard treatments specifically for this condition. ^{2 6 7 8 9}

Research Team

Chi Zhang, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combining etoposide and dexrazoxane synergizes with radiotherapy and improves survival in mice with central nervous system tumors. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

A phase II study of cisplatin therapy in recurrent childhood brain tumors. A report from the Childrens Cancer Study Group. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intracarotid chemotherapy with a combination of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU), cis-diaminedichloroplatinum (cisplatin), and 4'-O-demethyl-1-O-(4,6-O-2-thenylidene-beta-D-glucopyranosyl) epipodophyllotoxin (VM-26) in the treatment of primary and metastatic brain tumors. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Phase-I trial of intracarotid BCNU and cisplatin in patients with malignant intracerebral tumors. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Synergism between BCNU and irradiation in the treatment of anaplastic gliomas. An in vivo study using the avian sarcoma virus-induced glioma model. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Vorinostat as a radiosensitizer for brain metastasis: a phase I clinical trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Concurrent chemotherapy and radiotherapy in patients with brain tumors. [2005]

9. Ireland pubmed.ncbi.nlm.nih.gov

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