A Phase I Study of Cabazitaxel in Children and Teens with Persistent Solid Tumors

Protocol
13-021
Full Title
A Phase I-II Dose Finding, Safety and Efficacy Study of Cabazitaxel in Pediatric Patients with Refractory Solid Tumors Including Tumors of the Central Nervous System
Phase
I/II
Disease Status
Relapsed/Refractory
Purpose

Cabazitaxel is an anticancer drug that inhibits the ability of cancer cells to divide properly. It makes the “skeleton” in some cancer cells very stiff, so the cells can no longer grow or divide. It is approved for treating advanced prostate cancer, but its use in this study is considered investigational.

In this study, researchers want to find the highest dose of cabazitaxel that can be given safely in children and teenagers with malignant tumors that are not responding to treatment with other therapies. The investigators will also assess the preliminary effectiveness of cabazitaxel against these tumors. Cabazitaxel is given intravenously (by vein).

This study is being conducted by the POETIC (Pediatric Oncology Experimental Therapeutics Investigator Consortium) research group.
Co-Investigators

Pratilas, Christine, MD

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of a malignant solid tumor, including those of the central nervous system (brain and spinal cord), which is not responding to other therapies.
  • Patients must be at least age 2 but no older than 18.
  • At least 3 weeks must have passed since completion of prior chemotherapy and 4 weeks since major surgery, investigational therapies, or radiation therapy (6 months since radiation to the head or large areas) and entry into the study.
  • Patients who have had a bone marrow or stem cell transplant may not participate.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Disease(s)
Pediatric Brain Tumors: CNS Cancer
Primary Bone
Sarcomas
Solid Tumors
Locations
Related Diseases