St Petersburg, FLNCT04696029Now EnrollingIRB Ready

DRUG:Difluoromethylornithine Clinical Trial in St Petersburg, FL

Access cutting-edge drug:difluoromethylornithine treatment through this phase 2 clinical trial at a research site in St Petersburg. Study-provided care at no cost to qualified participants.

Sponsored by Giselle Sholler

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Expert Care in St Petersburg

Access drug:difluoromethylornithine specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related drug:difluoromethylornithine treatment provided free

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Check if you qualify for this drug:difluoromethylornithine clinical trial in St Petersburg, FL

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Why Participate?

  • No-Cost Study Care

  • Local to St Petersburg

    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 St Petersburg site if eligible
  4. 4Begin participation

About This DRUG:Difluoromethylornithine Study in St Petersburg

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma.

Sponsor: Giselle Sholler

Who Can Participate

Inclusion Criteria

Age: 0-21 years of age at diagnosis
Pathology All patients must either have a pathologically confirmed diagnosis of medulloblastoma with molecular grouping identified by either Nanostring or methylation profiling. Cohort 1- Molecular High Risk:
Metastatic non-MYC amplified Group 3
Metastatic Group 4
Metastatic non-WNT/non-SHH (Must be non-MYC amplified) Cohort 2- Molecular Very High Risk
Metastatic OR MYCN amplified OR TP53 mutant non-infant (\>3 yrs) SHH
MYC amplified Group 3
Non-WNT, non-SHH infant (\< 3 yrs) Cohort 3: Relapsed/Refractory Medulloblastoma
Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed:
Tumor imaging studies including: Brain and spine MRI
Lumbar Puncture only if previously positive
Bone Marrow aspiration/biopsy only if previously positive
This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to first dose of study drug, but must be done within a maximum of 4 weeks before first dose of study drug.
Disease Status: Subjects must have no evidence of disease, or stable\
residual nonbulky\*\
disease. \*Stable residual disease defined as non-progression over 2 separate imaging studies at least 6 weeks apart \*\*Non-bulky disease defined as maximal cross-sectional area \< 3cm\^2 at enrollment. Patients with leptomeningeal disease are allowed to participate on study.
Timing from prior therapy: Enrollment (first dose of DFMO) no later than 60 days after last dose of conventional chemotherapy. Patients who have undergone high dose chemotherapy (HDCT) with autologous stem cell transplantation (SCT) are eligible if more than 45 days have elapsed since date of last SCT.
Patients must have a Lansky or Karnofsky Performance Scale score of ≥ 50% (see Appendix II) and patients must have a life expectancy of ≥ 2 months.
All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to first dose of study drug unless otherwise indicated below.
Patients must have adequate organ functions at the time of registration:
Hematological: Hematological recovery as defined by ANC ≥750/μL, platelets ≥30 (non-transfused x 7 days)
Liver: Adequate liver function as defined by AST and ALT \<10x upper limit of normal
Renal: Adequate renal function defined as (perform one of the following): Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or a serum creatinine based on age/gender
Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or patients' legal representative).

Exclusion Criteria

BSA of \<0.25 m2
Metastatic disease outside of CNS
Relapsed/refractory patients who are radiation-naïve and age 5 years or older at time of enrollment
Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.
Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.
Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.

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 St Petersburg?

Yes, this clinical trial (NCT04696029) has an active research site in St Petersburg, 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.

DRUG:Difluoromethylornithine Treatment Options in St Petersburg, FL

If you're searching for drug:difluoromethylornithine treatment options in St Petersburg, FL, this clinical trial (NCT04696029) 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 St Petersburg research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced drug:difluoromethylornithine 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 drug:difluoromethylornithine clinical trials near you to find additional studies recruiting in your area.

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