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

Investigating Safety and Feasibility of a Treatment Being Studied in Pediatric Patients with Recurrent or Refractory Solid Tumors or Lymphoma

Recruiting
1 years - 21 years
All
Phase N/A
1 Location

Brief description of study.

This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.

Detailed description of study

This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: lymphoma
  • Age: 1 years - 21 years
  • 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

Updated on 19 Feb 2024. Study ID: PHO-BAYER-ADVL1721

This study investigates the safety and feasibility of an investigational medication for children with solid tumors or lymphoma that have come back or do not respond to standard treatments. Solid tumors are abnormal masses of tissue that can occur in any part of the body, and lymphoma is a type of cancer that affects the immune system. The study aims to see if the investigational medication can be a safe option for these patients.

Participants in the study will undergo various procedures to assess the effects of the investigational medication. These procedures may include physical exams, blood tests, and imaging tests like X-rays or MRIs. These tests help doctors understand how the body is responding to the treatment and ensure that it is safe for the participants.

  • Who can participate: Children aged 1 to 18 years with certain types of solid tumors such as neuroblastoma, osteosarcoma, rhabdomyosarcoma, or Ewing sarcoma, or lymphoma that do not respond to current treatments can participate. They must have good bone marrow, kidney, and liver function. Children with active infections or certain lung conditions cannot participate.
  • Study details: Participants will receive the investigational medication and will be monitored for safety and response to the treatment. Participant actions include undergoing physical exams, blood tests, and imaging tests like X-rays or MRIs to assess the effects of the treatment.

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