Is NCT05843253 recruiting in Aurora, CO?

Yes, NCT05843253 is currently recruiting participants at its Aurora, CO location. This brain cancer clinical trial is actively enrolling qualified participants.

How do I join the brain cancer clinical trial in Aurora?

To join this clinical trial in Aurora, 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 Aurora 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.

Brain Cancer Clinical Trial in Aurora, CO

About This Brain Cancer Study in Aurora

The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target. The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG, including DIPG.

Sponsor: Nationwide Children's Hospital

Who Can Participate

Inclusion Criteria

For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology, consistent with diffuse WHO grade 2-4 glioma

All other HGGs must be WHO grade 3 or 4. 1.3) Disease status: There are no disease status requirements for enrollment

Patients without measurable disease are eligible.

Patients with metastatic or multifocal disease or gliomatosis cerebri who received upfront CSI are eligible

Patients with a primary spinal HGG are eligible

Patients with secondary, radiation-related HGG are eligible.

Pathogenic alterations presumed to cause activation of cell cycle:

Amplification of CDK4 or CDK6

Deletion of CDKN2A, CDKN2B, or CDKN2C

Amplification of CCND1 or CCND2

Pathogenic alterations presumed to cause activation of the PI3K/mTOR pathway:

Deletion or mutation of PTEN

Mutation or amplification of PIK3CA

Mutation of PIK3R1

Deletion or mutation of TSC1 or TSC2

Patients with evidence of homozygous (biallelic) RB1 loss by sequencing are excluded from TarGeT-A

Patients whose tumors harbor other alterations suspected to activate the cell cycle and/or PI3K/mTOR pathway could potentially also be eligible, but only following consensus recommendation by the international multidisciplinary molecular screening committee.

For Stratum E: H3G34 (R/V) mutation 2.2) Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of ag. 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. 2.3) Prior Therapy for HGG:

Surgery, RT, dexamethasone are permissible. Temozolomide administered concurrently with RT is permissible. Avastin/bevacizumab use is permitted given the last dose was administered \> 21 days prior to enrollment. No other prior anticancer therapy for HGG will be allowed.

Patients must have received photon or proton RT.

Patients must have started RT \< 42 calendar days from initial diagnosis defined as the date of diagnostic biopsy or resection. If a patient underwent 2 upfront surgeries (e.g., biopsy then resection or debulking), this is the date of the second surgery.

RT delivered via photon or proton beam, must have been administered at a standard dose including (54 Gy in 30 fractions for DIPG, 54-59.4 Gy in 30-33 fractions), 45 Gy-54 Gy for primary spinal disease, and/or 36 Gy-39.6 Gy craniospinal for patients with spinal or leptomeningeal metastatic disease with supplemental boost to 45-54 Gy for metastasis within the thecal sac and 54 Gy-60 Gy for intracranial metastasis. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.

Patients must enroll and start treatment No later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT. 2.4) Organ Function Requirements 2.4.1) Adequate Bone Marrow Function Defined as:

Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3

Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)

Hemoglobin \>8 g/dL (may be transfused) 2.4.2) Adequate Renal Function Defined as:

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

Maximum serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age/gender as follows: 1 to \< 2 years=0.6 mg/dL for males and females; 2 to \< 6 years=0.8 mg/dL for males and females; 6 to \< 10 years= 1.0 mg/dL for males and females; 10 to \< 13 years=1.2 mg/dL for males and females. 13 to \< 16 years=1.5 mg/dL for males and 1.4 mg/dL for females. 2.4.3) Adequate Liver Function Defined as:

Total bilirubin must be ≤ 1.5 times institutional upper limit of normal for age

AST(SGOT)/ALT(SGPT) ≤ 3 times institutional upper limit of normal

Serum albumin ≥ 2g/dL 2.4.4) Adequate Cardiac Function Defined as:

Ejection fraction of ≥ 50% by echocardiogram

QTc ≤ 450 msec (by Bazett formula) 2.4.5) Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if well-controlled on anticonvulsants that are not strong inducers or inhibitors of CYP3A4/5. 2.4.6) Adequate Pulmonary Function Defined as: No evidence of dyspnea at rest, and a pulse oximetry \>94% on room air if there is clinical indication for determination. 2.5) Ability to take medications by mouth: For ribociclib and everolimus strata, patients must be able to take study medications by mouth as administration via NG/NJ/G tube is not allowed. 2.6) Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines 2.7) Contraception: Male and female patients of childbearing potential must be willing to use a highly effective contraception method.

Exclusion Criteria

Pregnant or Breast-Feeding Pregnant or breast-feeding women will not be entered on this study due to known potential risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use at least one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy A highly effective contraception method is defined as one that results in a low failure rate (\<1% per year) when used consistently and correctly. The following are considered highly effective contraception methods:

Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation.

Progesterone-only hormonal contraception associated with inhibition of ovulation.

Intra Uterine Device (IUD)

Intra Uterine hormone releasing system

Bilateral tubal occlusion

Vasectomized partner

Sexual abstinence (avoiding having heterosexual intercourse) The following contraceptive measures are NOT considered effective

Progesterone-only hormonal contraception (birth control pill) that that does NOT stop ovulation

Male or female condom with or without spermicide

Cap, diaphragm or sponge with spermicide

Concomitant Medications

Patients receiving corticosteroids are eligible. The use of corticosteroids must be reported.

Patients who are currently receiving another investigational drug are not eligible.

Patients who are currently receiving other anti-cancer agents are not eligible, with the exception of temozolomide given concurrently with RT only.

Patients who are receiving enzyme inducing anticonvulsants that are strong inducers or inhibitors of CYP3A4/5 are not eligible.

Patients who are receiving strong inducers or inhibitors of CYP3A4/5 are not eligible and should be avoided from 14 days prior to enrollment to the end of the study.

Patients who are receiving medications known to prolong QTc interval are not eligible.

Patients who are receiving therapeutic anticoagulation with warfarin or other coumadin-derived anticoagulants are not eligible. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed as long as the patient has adequate coagulation defined as aPTT \< 1.5Xs ULN and INR \< 1.5.

Patients who have an uncontrolled infection are not eligible.

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.

Patients with known clinically significant active malabsorption syndrome or other condition that could affect absorption are not eligible.

Patients with prior or ongoing clinically significant medical or psychiatric condition that, in the investigator's opinion, could affect the safety of the subject, or could impair the assessment of study results are not eligible.

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 Aurora?

Yes, this clinical trial (NCT05843253) has an active research site in Aurora, CO 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.

Brain Cancer Treatment Options in Aurora, CO

If you're searching for brain cancer treatment options in Aurora, CO, this clinical trial (NCT05843253) 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 Aurora research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced brain cancer 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 brain cancer clinical trials near you to find additional studies recruiting in your area.

Brain Cancer Clinical Trial in Aurora, CO

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