A Non-randomized Open-label Multi-center Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma
James Croop, MD, PhD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
lymphoma,solid tumor
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Age: Between 1 Years - 21 Years
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Gender: All
Inclusion Criteria
Confirmation of diagnosis:
Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received greater than or equal to 1 prior line of therapy.
Phase II: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma.
Patients with solid tumors must have measurable or evaluable (for neuroblastoma and Ewing sarcoma) disease.
Adequate bone marrow, renal and liver function.
Exclusion Criteria
Active or uncontrolled infection
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
Diabetes mellitus
Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines)
Patients with central nervous system (CNS) malignancies
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