Is NCT04299191 recruiting in Edison, NJ?

Yes, NCT04299191 is currently recruiting participants at its Edison, NJ location. This malignant glioma clinical trial is actively enrolling qualified participants.

How do I join the malignant glioma clinical trial in Edison?

To join this clinical trial in Edison, 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 Edison 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.

Malignant Glioma Clinical Trial in Edison, NJ

About This Malignant Glioma Study in Edison

An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recomm

Sponsor: Laminar Pharmaceuticals

Who Can Participate

Inclusion Criteria

Age \<18 years

Diagnosis: Patients must have a histologically- or cytologically-confirmed advanced solid malignancy that is progressive, recurrent or refractory to standard-of-care treatment, or for which there is no standard therapy. Examples of tumors that lack a standard therapy include, but are not limited to, high-grade glioma, diffuse midline glioma, and diffuse intrinsic pontine glioma. For patients with a radiographic diagnosis of diffuse midline glioma or diffuse intrinsic pontine glioma, histologic or cytologic confirmation of their diagnosis is not required.

Timing of therapy:

Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment.

All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section.

Patients must have a Lansky or Karnofsky performance status score of ≥ 50%, corresponding to ECOG categories of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age. Patients 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.

Able to swallow and ingest oral medication or have a NG or G-tube for drug administration

Able to undergo adequate tumor imaging, via computerized tomography (CT) or magnetic resonance imaging (MRI) scans or any other standardized tumor assessment method based on tumor type (PET, MIBG, etc) to evaluate disease evolution

Adequate hematologic, renal, liver function as demonstrated by laboratory values:

ANC ≥ 1,000/ul

Hemoglobin ≥8.0 gm/dl

Platelet count ≥ 100,000/ul

Adequate Liver Function Defined As

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and

SGPT (ALT) \< 2.5 x upper limit of normal (ULN) for age.

Adequate Renal Function Defined As Either

Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73m2

or a serum creatinine less than or equal to the institutional normal for age

No history of QTc prolongation, and a normal QTc interval at screening/baseline (QTc ≤450 msec)

No evidence of a bleeding diathesis

Negative pregnancy test in women of childbearing potential within 7 days of initiating investigational therapy

Patient or legal guardian must give written, informed consent or assent (when applicable) -

Recent mothers must agree not to breast feed while receiving medications on study.

Exclusion Criteria

Age ≥ 18 years

Known hypersensitivity to any component of the study drug

Use of any other investigational drug within five half-lives of that drug prior to the first dose of LAM561

Any National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE version 4.0) \>Grade 1 toxicities from prior chemotherapy or radiotherapy that could impact on safety outcome assessment

Any surgery within 14 days prior to the first dose of LAM561 (excluding shunt or line insertion)

Known \>Grade 1 intracranial or intratumoral hemorrhage either by CT or MRI scan within the last 1 month. Patients with resolving hemorrhage changes, punctuate hemorrhage or hemosiderin may enter the study

A history of significant or uncontrolled cardiovascular disease, including New York Heart Association Class III-IV heart failure, a left ventricular ejection fraction which is clinically significantly abnormal as measured by 2-dimensional (2-D) echocardiogram or Multi Gated Acquisition(MUGA) scan, unstable angina or myocardial infarction within the preceding 6 months

Known impairment of gastrointestinal (GI) function that could alter the absorption of study drug (e.g. active Crohn's disease, malabsorption syndrome or states, unresolved diarrhea, small bowel resection or gastric by-pass surgery)

Patients who are unable to take oral medications because of significant uncontrolled vomiting will be excluded.

A history of uncontrolled hyperlipidemia and/or the need for concurrent lipid lowering therapy

Concurrent severe and/or uncontrolled other medical disease (e.g. uncontrolled diabetes mellitus, active uncontrolled infection) that could compromise participation in the study

Need for warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide,glyburide or nateglanide)

Any serious and/or unstable pre-existing medical, psychiatric or other condition which in the Investigator's opinion could interfere with subject safety, obtaining written informed consent, or compliance with the study protocol

Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females.

Lactating females must agree they will not breastfeed a child while on this study.

Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of 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 Edison?

Yes, this clinical trial (NCT04299191) has an active research site in Edison, NJ 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.

Malignant Glioma Treatment Options in Edison, NJ

If you're searching for malignant glioma treatment options in Edison, NJ, this clinical trial (NCT04299191) 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 Edison research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced malignant 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 malignant glioma clinical trials near you to find additional studies recruiting in your area.

Malignant Glioma Clinical Trial in Edison, NJ

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