Is NCT06172296 recruiting in Downey, CA?

Yes, NCT06172296 is currently recruiting participants at its Downey, CA location. This neuroblastoma clinical trial is actively enrolling qualified participants.

How do I join the neuroblastoma clinical trial in Downey?

To join this clinical trial in Downey, 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 Downey 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.

Neuroblastoma Clinical Trial in Downey, CA

About This Neuroblastoma Study in Downey

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab bi

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131

≤ 30 years at the time of initial diagnosis with high-risk disease

Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines

Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:

Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification

Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)

Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy

Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)

Patients must have a body surface area (BSA) ≥ 0.25 m\^2

No prior anti-cancer therapy except as outlined below:

Patients initially recognized to have high-risk disease treated with topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing, and with consent

Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria

Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis

Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

A serum creatinine based on age/sex as follows:

1 month to \< 6 months: Male 0.4 mg/dL and female 0.4mg/dL

6 months to \< 1 year: Male 0.5 mg/dL and female 0.5 mg/dL

1 to \< 2 years: Male 0.6 mg/dL and female 0.6 mg/dL

2 to \< 6 years: Male 0.8 mg/dL and female 0.8 mg/dL

6 to \< 10 years: Male 1 mg/dL and female 1 mg/dL

10 to \< 13 years: Male 1.2 mg/dL and female 1.2 mg/dL

13 to \< 16 years: Male 1.5 mg/dL and female 1.4 mg/dL

≥ 16 years: Male 1.7 mg/dL and female 1.4 mg/dL

The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)

or a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 or

or a GFR ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)

Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility

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

Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \[ALT\]) ≤ 10 x ULN\

Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L

Shortening fraction of ≥ 27% by echocardiogram, or

Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram

Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection: No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure

Exclusion Criteria

Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features

Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features

Patients with known bone marrow failure syndromes

Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable

Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy

Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential

Lactating females who plan to breastfeed their infants

Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

All patients and/or their parents or legal guardians must sign a written informed consent

All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

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 Downey?

Yes, this clinical trial (NCT06172296) has an active research site in Downey, CA 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.

Neuroblastoma Treatment Options in Downey, CA

If you're searching for neuroblastoma treatment options in Downey, CA, this clinical trial (NCT06172296) 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 Downey research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced neuroblastoma 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 neuroblastoma clinical trials near you to find additional studies recruiting in your area.

Neuroblastoma Clinical Trial in Downey, CA

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