Gainesville, FLNCT06514898Now EnrollingIRB Ready

Recurrent Group 3 Medulloblastoma Clinical Trial in Gainesville, FL

Access cutting-edge recurrent group 3 medulloblastoma treatment through this phase 1 clinical trial at a research site in Gainesville. Study-provided care at no cost to qualified participants.

Sponsored by University of Florida

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Expert Care in Gainesville

Access recurrent group 3 medulloblastoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent group 3 medulloblastoma treatment provided free

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Check if you qualify for this recurrent group 3 medulloblastoma clinical trial in Gainesville, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Gainesville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Gainesville site if eligible
  4. 4Begin participation

About This Recurrent Group 3 Medulloblastoma Study in Gainesville

This is a pilot study in a small number of children and young adults with suspected recurrent/progressive medulloblastoma (MB) looking at the feasibility and safety of adoptive cell therapy plus PD-1 blockade.

Sponsor: University of Florida

Who Can Participate

Inclusion Criteria

Children and young adults ages 4-30 years with suspected recurrence/progression of Group 3 or 4 (non-SHH/non-WNT) MB since completion of definitive focal +/- craniospinal irradiation who are a candidate for surgical resection or biopsy. Of the 6 evaluable subjects, a minimum of 3 slots must be reserved for patients with confirmed Group 4 MB. Patients who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation) are eligible for enrollment at first disease recurrence/progression.
Patients must currently be prescribed and approved to receive pembrolizumab therapy (patients who have progressed on anti-PD-1 targeting therapy but are otherwise eligible may be enrolled to receive combination with immunotherapy. Patients who have been previously treated with anti-PD-1 targeting therapy alone or in combination with other agents and discontinued for reasons other than toxicity may be enrolled).
Must be a candidate for surgery/biopsy Or tumor tissue obtained clinically, has been previously stored in a qualified biorepository suitable for tumor RNA extraction and amplification and sample is made available to the PI.
Karnofsky or Lansky Performance Status (KPS) ≥ 60% (KPS for \> 16 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for \< 16 years of age)
Adequate bone marrow and organ function as defined below:
ANC ≥ 1,000/mcL (unsupported)
Platelets ≥ 100,000/mcL (unsupported for at least 3 days)
Hemoglobin ≥ 9 g/dL (may be supported)
Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN
Serum total bilirubin ≤ 1.5 x IULN for age OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN for age
AST (SGOT) and ALT (SGPT) ≤ 3 x IULN for age
Cardiac shortening fraction ≥27% or LVEF ≥50% by echocardiogram
Adequate pulmonary function defined as baseline pulse oximetry of ≥92% on room air
For females of childbearing potential, negative serum pregnancy test at enrollment
For women of childbearing potential (WOCBP) must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. or For males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
Signed informed consent by patient and/or legally authorized representative

Exclusion Criteria

this study:
Prior discontinuation of PD-1 inhibitor treatment due to toxicity.
Corticosteroids equivalent to ≥ 4mg dexamethasone daily.
Known HIV, Hepatitis B, or Hepatitis C seropositive.
Known active infection or immunosuppressive disease.
Known autoimmune disease requiring medical management with immunosuppressant.
Pregnancy or lactation, due to possible adverse effects on the developing fetus or infant.
Treatment with another investigational drug or other intervention within 30 days prior to projected first dose of study treatment (Priming phase with TTRNA-DC).
Known severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization.
Transmural myocardial infarction within the last 6 months.
Acute bacterial or fungal infection requiring intravenous antibiotics at time of enrollment.
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy.
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT06514898) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Group 3 Medulloblastoma Treatment Options in Gainesville, FL

If you're searching for recurrent group 3 medulloblastoma treatment options in Gainesville, FL, this clinical trial (NCT06514898) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced recurrent group 3 medulloblastoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent group 3 medulloblastoma clinical trials near you to find additional studies recruiting in your area.

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