Phase 2 Brain Cancer Trial, Recruiting NCT04222062 Sponsor: University of Nebraska Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT04222062
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

"Who might be able to join this trial:

  • People who are 18 years of age or older (or 19 and older if living in Nebraska).
  • People whose overall health and cancer situation falls within a certain range, as measured by standard medical scoring tools used for brain cancer patients, and who have a functional ability score of 60 or above out of 100 (confirm with trial site).
  • People who have a known or suspected solid cancer that has spread to the brain, with up to four brain tumours, each no larger than 4 cm, where surgery is planned to remove at least one tumour and a specific type of chemotherapy wafer (called Gliadel) is planned to be placed at one surgical site.
  • People whose blood test results show it is safe for them to have surgery, as judged by their neurosurgeon (blood transfusions are allowed beforehand if needed to reach the required levels).
  • Women who could become pregnant must have had a negative pregnancy test within 7 days of starting the study. Women who are not considered to be of childbearing potential include those aged 55 or older with no periods for two years, or anyone who has had their uterus and/or both ovaries surgically removed.
  • People with a normal blood clotting result (a specific clotting measurement called INR must be 1.3 or below).
  • People whose doctor estimates they are likely to live for at least 3 months or more.
  • People who are willing and able to give their consent and follow the requirements of the trial.

Who may not be able to join:

  • People who have previously had surgery or radiation treatment to the area of the brain being considered for surgery in this trial.
  • People who have previously had whole-brain radiation therapy.
  • People whose cancer is specifically lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer.
  • People whose cancer has spread to the lining of the brain and spinal cord (a condition called leptomeningeal disease).
  • People who have a brain-related degenerative condition, such as dementia.
  • People whose brain tumour is larger than 4 cm.
  • People with a functional ability score below 60 out of 100 on the standard medical scoring tool used in this trial (confirm with trial site).
  • People who are unable or unwilling to follow the requirements of the trial.
  • People with another significant medical, physical, or mental health condition, or abnormal test results, that the trial doctor believes could interfere with the trial or make it unsafe to participate.
  • People who are already taking part in another clinical trial for a treatment.
  • People with serious heart or lung conditions, including: moderate-to-severe heart failure within the past 6 months (unless it is well managed with medication and causing no symptoms); uncontrolled or significant heart disease; serious irregular heart rhythms; or significant breathing difficulties rated at a certain level of severity (confirm with trial site).
  • People with a metabolic or psychological condition that, in the trial doctor's opinion, may affect their ability to follow the trial or may put them at greater risk of complications.
  • People who have a condition that causes abnormal bleeding, or who need to take blood-thinning or anti-clotting medications (including certain common pain relief medicines such as anti-inflammatories) at the time of planned surgery, where stopping those medications is not possible.
  • People who are unable to have MRI scans.

Important: Always verify eligibility with the trial site directly before applying."

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Michele Aizenberg, MD, University of Nebraska

Phone: 402-559-0963

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Nebraska
Registry
ClinicalTrials.gov
Start date
6 November 2020
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov