Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors (NCT02574728)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants with any of the following tumors who have experienced relapse following front-line therapy, or who are refractory to front-line therapy, and participants with tumors that carry a poor prognosis and have no known standard curative therapy
2. Brain tumors of all World Health Organization (WHO) grades, except diffuse intrinsic pontine glioma (DIPG) - enrollment in the brain tumor stratum is closed
3. Extracranial solid tumors including histiocytoses
4. Participants must have had a histologic verification of malignancy at original diagnosis or relapse, except in participants with optic pathway gliomas, or participants with pineal tumors and elevations of serum or cerebrospinal fluid (CSF) alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (beta-HCG)
5. Tissue blocks or slides must be sent
6. Participants must have radiographically measurable disease at the time of study enrollment to be eligible. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as tumor that is measurable (≥ 10 mm) in two perpendicular diameters on MRI and visible on more than one slice. For all patients, tumors that are located in a previously irradiated area may be considered measurable if the lesion has shown tumor growth after radiation or has been biopsied and proven to have active disease.
7. Participant's current disease state must be one for which there is no known curative therapy
8. Karnofsky performance level of greater than or equal to 50 percent for participants who are greater than 16 years of age at the time of screening
9. Lansky performance level of greater than or equal to 50 percent for participants who are less than or equal to 16 years of age at the time of screening
10. Fully recovered from acute toxic effects of all prior anti-cancer therapy
11. Adequate bone marrow function as deemed by the protocol at the time of screening
12. Adequate renal function as deemed by the study protocol at the time of screening

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

• Phoenix Children's Hospital — Phoenix, Arizona
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware
• Children's Healthcare of Atlanta-Egleston — Atlanta, Georgia
• Children's Healthcare of Atlanta, Scottish Rite — Atlanta, Georgia
• Children's Mercy Hospital — Kansas City, Missouri
• University of Virginia Health System — Charlottesville, Virginia

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.