Is NCT04254419 recruiting in Columbus, OH?

Yes, NCT04254419 is currently recruiting participants at its Columbus, OH location. This high grade glioma clinical trial is actively enrolling qualified participants.

How do I join the high grade glioma clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

High Grade Glioma Clinical Trial in Columbus, OH

About This High Grade Glioma Study in Columbus

Each patient will receive up to 12 cycles of TGFβi NK cell infusions. Each cycle will be of 4 weeks duration. During the first 3 weeks, TGFβi NK cells will be infused once weekly. The 4th week will be a rest week. TGFβi NK cell infusions should be delivered at least 3 days apart (e.g., Friday of Week 1 and Monday of Week 2). Dose will be escalated in an inter-patient stepwise fashion consisting of 3 dose levels.

Sponsor: Nationwide Children's Hospital

Who Can Participate

Inclusion Criteria

Diagnosis: Recurrent, refractory, or progressive malignant CNS tumor

Patients with a histologically confirmed diagnosis of a CNS tumor that is recurrent, progressive, or refractory with the exception of diffuse midline gliomas (DMG) or Diffuse Intrinsic Pontine Gliomas (DIPG). All tumors must have histologic verification at either the time of diagnosis or recurrence.

Patients should be deemed candidate for placement of an Ommaya reservoir placed intra-cavitary/intra-tumoral or a programable VP shunt.

Measurable residual tumor after surgery is not required for study entry.

Resection cavity needs to be at least 2 cm x 2 cm in two dimensions on imaging for patients deemed as candidates for an intratumoral infusion via an Ommaya reservoir.

Performance score: Lansky score of 50 or greater if ≤ 16 years of age or a Karnofsky score of 50 or greater if \> 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

Adequate bone marrow function, without transfusion or growth factors within 21 days of NK cell administration.

Adequate liver function

Adequate Renal Function

Prothrombin time/international normalized ratio

Patients of child-bearing potential must agree to use adequate contraception

Adequate neurologic function defined Prior Therapy:

Chemotherapy

All patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days of nitrosourea.

For patients who have received prior bevacizumab, at least 6 weeks must have elapsed prior to enrollment.

Biologic or investigational agent (anti-neoplastic, non-myelosuppressive):

Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 14 days prior to study enrollment.

For agents with known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur.

At least 12 weeks since the completion of any immunotherapies or cell therapies.

Radiation Therapy

Focal radiation therapy \> 6 weeks prior to enrollment.

Craniospinal irradiation \>12 weeks.

Stem Cell Transplant. Patient must be:

≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease.

≥ 3 months since autologous stem cell transplant prior to enrollment. • Growth Factors

Patients must be off all colony- forming growth factor(s) for at least 1 week prior to enrollment (e.g., filgrastim, sargramostim or erythropoietin).

2 weeks must have elapsed if patients received long-acting formulations. • Corticosteroids

Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment.

Exclusion Criteria

Patients with intra- or extra-CNS metastasis or multi-focal disease.

Patients with diffuse midline gliomas or Diffuse Intrinsic Pontine Gliomas (primary or recurrent).

Pregnant or lactating patients.

Participants who are receiving any other investigational agents.

Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions.

Any medical condition that precludes surgery.

Patients with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV), or an auto- immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible.

Evidence of bleeding diathesis or use of anticoagulant medication or any medication which may increase the risk of bleeding.

Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.

History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate

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 Columbus?

Yes, this clinical trial (NCT04254419) has an active research site in Columbus, OH 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.

High Grade Glioma Treatment Options in Columbus, OH

If you're searching for high grade glioma treatment options in Columbus, OH, this clinical trial (NCT04254419) 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 Columbus research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced high grade glioma 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 high grade glioma clinical trials near you to find additional studies recruiting in your area.

High Grade Glioma Clinical Trial in Columbus, OH

Expert Care in Columbus

IRB Approved

No-Cost Care

Apply for This Columbus Location

Why Participate?

Simple Process