• Next Bi-Annual Meeting:

    February 5-7, 2025

Clinical Trials

Since POETIC’s inception, numerous trials have been developed and conducted to discover novel treatments for infants, children, and adolescents with refractory malignancies. POETIC’s goal includes providing and conducting early clinical trials with a primary emphasis on rational, biologically based drug development. We use findings from our biology initiatives to design clinical trials that encourage inclusion of promising agents. These trials have helped to increase the access to new agents in treating pediatric cancer patients.

Clinical Trials

Since POETIC’s inception, numerous trials have been developed and conducted to discover novel treatments for infants, children, and adolescents with refractory malignancies. POETIC’s goal includes providing and conducting early clinical trials with a primary emphasis on rational, biologically based drug development. We use findings from our biology initiatives to design clinical trials that encourage inclusion of promising agents. These trials have helped to increase the access to new agents in treating pediatric cancer patients.

Clinical Trials2024-06-17T21:13:26+00:00

Active Clinical Trials

TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II2024-05-14T01:38:19+00:00
The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.

Sponsor: Tanja A. Gruber, MD

Protocol: POE23-01

Principal investigator: Tanja A. Gruber, MD

Site: 27 sites across North America

Estimated accrual years: 5.0

PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy2024-06-22T01:16:22+00:00
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.

Sponsor: Dr. Kamens

Protocol: POE22-01

Principal investigator: Jennifer Kamens, MD

Site: Stanford University

Estimated accrual years: 2.0

Idasanutlin in combination with either chemotherapy or Venetoclax in the treatment of pediatric and young patients with relapsed/refractory acute leukemias or solid tumors2024-05-14T01:38:37+00:00

Sponsor: Genentech

Protocol: GO40871

Estimated accrual years: 5 years (in 3 phases)

Safety and dose finding study of Neratinib in children and young adults with cancer that has returned or not responded to treatment2024-05-14T01:38:47+00:00
A Phase I/II study of Neratinib in pediatric patients with relapsed or refractory solid tumors or hematologic malignancies

Sponsor: Puma

Protocol: POE16-01

Principal investigator: Tanya Trippett, MD

Site: Memorial Sloan Kettering Cancer Center

Estimated accrual years: 1.0 (Phase I); 1.5 (Phase II)

Completed Studies

  • Carfilzomib in combination with Cyclophosphamide and Etoposide for children

  • Safety and pharmacokinetics of Cobimetinib in pediatric and young adult participants with previously treated solid tumors

  • Cyclophosphamide, Topotecan, and Bevacizumab (CTB) in patients with relapsed/refractory Ewing’s Sarcoma and Neuroblastoma

  • Clinical study of Vorinostat in combination with Etoposide in pediatric patients < 21 years at diagnosis with refractory solid tumors

  • External beam radiation therapy and Cetuximab followed by Irinotecan and Cetuximab for children and young adults with newly diagnosed diffuse pontine tumors and high-grade astrocytomas

  • Everolimus (RAD001) for children with chemotherapy-refractory progressive or recurrent low-grade gliomas

  • Plerixafor as a chemosensitizing agent for relapsed acute leukemia and MDS in pediatric patients

  • Phase I trial of Anti-PD-L1 in patients with solid tumors

  • Phase I trial of Cabazitaxel in patients with solid tumors including CNS

  • Phase I trial of 17-AAG in patients with solid tumors and leukemia

  • Phase I trial of Cetuximab and Irinotecan in patients with solid tumors including CNS

  • Phase I trial of Oxaliplatin, Fluorouracil, and Leucovorin  in patients with solid tumors

  • Phase I trial of Clofarabine and Cyclophosphamide  in patients with leukemia

  • Phase I trial of Ridaforolimus in patients with solid tumors

  • Safety and pharmacokinetics of Atezolisumb (MPDL3280A) in pediatric and young adults patients with previously treated solid tumors

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