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Through this multi-center Children’s Oncology Group study, researchers are evaluating the effects of the drug copanlisib for participants suffering from cancer that has returned or did not respond to standard treatments. Researchers will be evaluating dosage amounts, drug tolerability and whether tumors respond to copanlisib. Approved for adults with certain cancers, copanlisib targets and blocks phospho-inositol-3-kinase (PI3K), an enzyme that contributes to growth of tumor cells.
The Phase I part of the study is accepting participants with a solid tumor or lymphoma malignancy for which there is no standard treatment or where the standard treatment is no longer effective. The Phase II study is accepting patients with confirmed neuroblastoma, osteosarcoma, rhabdomyosarcoma, or Ewing sarcoma. The age range for participants is 6 months to 21 years.
Males and Females: Ages 6 months to 21 years
IIn 4-week cycles, participants will be provided the study drugs via intravenous infusion on days 1, 8 and 15. During visits for infusions, participants will receive examinations, testing and blood draws. Imaging will also be done at certain intervals.
Visits: 3 visits for infusions in each 28-day cycle
Duration: Patients will remain on treatment until disease progression or unacceptable side effects. When stopping treatment patients will be followed for two years after completing study drug
Children’s Oncology Group (ADVL1721)
National Cancer Institute
Bayer HealthCare Pharmaceuticals
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
Andrew Bukowinski, MD, MS
For more information about the study or enrollment, please contact:
Andrew Bukowinski, MD, MS
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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