Is NCT05954858 recruiting in New York, NY?

Yes, NCT05954858 is currently recruiting participants at its New York, NY location. This glioma, malignant clinical trial is actively enrolling qualified participants.

How do I join the glioma, malignant clinical trial in New York?

To join this clinical trial in New York, 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 New York 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.

Glioma, Malignant Clinical Trial in New York, NY

About This Glioma, Malignant Study in New York

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

Sponsor: Northwell Health

Who Can Participate

Inclusion Criteria

Subject is a male or female 18 years of age or older.

Subject is undergoing planned resection of known or suspected GBM.

Subject has a Karnofsky Performance Status (KPS) 70% or greater.

Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.

Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.

Subject must be able to undergo MRI evaluation.

Subject meets the following laboratory criteria:

White blood count ≥ 3,000/μL

Absolute neutrophil count ≥ 1,500/μL

Platelets ≥ 100,000/μL

Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed)

Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN

Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN

Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.

Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.

Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted). Inclusion criteria considered during surgery:

Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).

TPFF and/or pericranial flap is technically feasible.

Exclusion Criteria

Subject, if female, is pregnant or is breast feeding.

Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.

Subject intends to participate in another clinical trial

Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.

Subject has an active infection requiring treatment.

Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.

Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment

Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.

Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

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 New York?

Yes, this clinical trial (NCT05954858) has an active research site in New York, NY 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.

Glioma, Malignant Treatment Options in New York, NY

If you're searching for glioma, malignant treatment options in New York, NY, this clinical trial (NCT05954858) 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 New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced glioma, malignant 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 glioma, malignant clinical trials near you to find additional studies recruiting in your area.

Glioma, Malignant Clinical Trial in New York, NY

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IRB Approved

No-Cost Care

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