Chapel Hill, NCNCT07560826Now EnrollingIRB Ready

Osteosarcoma in Children Clinical Trial in Chapel Hill, NC

Access cutting-edge osteosarcoma in children treatment through this phase 2 clinical trial at a research site in Chapel Hill. Study-provided care at no cost to qualified participants.

Sponsored by Wake Forest University Health Sciences

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Expert Care in Chapel Hill

Access osteosarcoma in children specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related osteosarcoma in children treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Chapel Hill

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chapel Hill site if eligible
  4. 4Begin participation

About This Osteosarcoma in Children Study in Chapel Hill

The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment. The main questions this study aims to answer are: * Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days? * Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers? Researchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels. Participants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.

Sponsor: Wake Forest University Health Sciences

Who Can Participate

Inclusion Criteria

Participants with localized or metastatic high-grade osteosarcoma.
Participants must be ≤ 22 years of age at the time of consent.
Participants must have a body surface area of greater than or equal to 0.8 m2.
Participants receiving or planning to receive induction/neoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm/m2 (maximum 20 gm). NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm/m2 (maximum 20 gm).
Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.
Participants must meet minimum organ function requirements to receive HD-MTX:
Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT/SGPT) ≤ 135 U/L for age at the time of consent.
Adequate renal function defined as: a serum creatinine based on age/gender OR - a 24-hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL/min/1.73 m2 for age at the time of consent.
Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g/dL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment)
Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo). NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol.
Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin).
Participants must be willing and able to comply with all study procedures for the entire length of the study.

Exclusion Criteria

Female participants who are pregnant and/or lactating and breast feeding their infant(s). NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol.
Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.

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 Chapel Hill?

Yes, this clinical trial (NCT07560826) has an active research site in Chapel Hill, NC 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.

Osteosarcoma in Children Treatment Options in Chapel Hill, NC

If you're searching for osteosarcoma in children treatment options in Chapel Hill, NC, this clinical trial (NCT07560826) 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 Chapel Hill research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced osteosarcoma in children 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 osteosarcoma in children clinical trials near you to find additional studies recruiting in your area.

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