Solid Tumor and Lymphoma Treatment with PI3K – Phase I/II

Study of PI3K Inhibitor Copanlisib in Pediatric Patients with Relapsed/Refractory Solid Tumors or Lymphoma

Protocol Description

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.

Study Level: Phase I/II

Eligibility Criteria

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

Requirements

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

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1721)
National Cancer Institute
Bayer HealthCare Pharmaceuticals

Primary Investigator

Andrew Bukowinski, MD, MS

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski, MD, MS
412-692-5055