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Back to Brain Cancer
Phase 1 Brain Cancer Trial, Recruiting
NCT03911388
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:
- You are at least 3 years old and younger than 22 years old
- You have a cancerous brain tumor in the cerebellum (the lower back part of the brain) that has been confirmed by a tissue sample, and the tumor has come back or kept growing despite standard treatments like surgery, radiation, or chemotherapy
- Your tumor is between 1.0 cm and 3.0 cm in size and can be reached safely by surgery, as shown on an MRI scan (larger tumors may qualify if they can be partially removed to bring them within this size range)
- You have fully recovered from the side effects of any previous cancer treatments before joining the study
- Your last dose of standard chemotherapy was at least 3 weeks ago (or at least 6 weeks ago for a specific type called nitrosourea)
- Your last dose of an experimental or biological treatment was at least 7 days ago, and you have recovered from any related side effects (confirm with trial site for specific agents)
- If you previously received a viral therapy, it was at least 3 months ago and you have recovered from any related side effects
- Your last dose of monoclonal antibody treatment was at least 21 days ago
- Any major radiation treatment to your spine or whole body was at least 3 months ago, and any targeted or palliative radiation was at least 28 days ago
- If you had a bone marrow transplant using your own cells, it was at least 3 months ago
- Your blood counts, kidney function, and liver function are within acceptable healthy ranges (confirm specific values with trial site)
- You are well enough to carry out some daily activities, measured by an age-appropriate health score (confirm with trial site)
- Your life expectancy is at least 8 weeks
- You or your parent/legal guardian is able to provide written consent to participate
Who may not be able to join:
- Your previous treatments do not meet the timing and recovery guidelines described above
- Your tumor has spread widely across 3 or more areas of the brain in a diffuse pattern
- You currently have an active infection, very low white blood cell count, or another medical condition that makes surgery unsafe
- You are pregnant or breastfeeding
- You were diagnosed with a brain or central nervous system (CNS) infection, or brain inflammation (encephalitis), within the last 3 months, or are currently being treated for these conditions or for multiple sclerosis
- Delivering the treatment would require it to be injected into the fluid-filled spaces of the brain (ventricles) or into the brainstem
- You needed an increased dose of steroids in the week before the planned treatment, or you currently require more than 2 mg of dexamethasone per day
- You are known to be HIV positive
- You are currently taking antiviral medications that target the herpes virus (such as acyclovir or valacyclovir) or any drugs that suppress the immune system, other than low-dose steroids (confirm with trial site)
- You have another active cancer at the same time
- You are currently receiving any other cancer treatment or taking part in another experimental drug trial
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.
Phase 1: approximately ~10% 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: Gregory Friedman, MD, M.D. Anderson Cancer Center
Phone: 832-750-5661l
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 1
Sponsor
Registry
ClinicalTrials.gov
Start date
12 September 2019
Est. completion
1 September 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 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.