Purpose

This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia.

Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved for the disease being treated in this study. Since carfilzomib has not yet been used in this setting to treat this condition, the investigators must first find the best dose to give. The investigators are looking for the highest dose of carfilzomib that can be given safely. Therefore, not all children taking part in this study will receive the same dose of the study drug in the first part of the trial.

Category

IRB Number
20160206HU
NCT Number
NCT02512926
Open to Enrollment
Yes
Sponsor
Phoenix Children's Hospital -



Study Contact

Local Recruitment Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Principal Investigator
Anne-Marie Langevin

Regulatory Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between 6 Months and 29 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 1
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Relapsed Solid Tumors
    2. Refractory Solid Tumors
    3. Leukemias
    4. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Carfilzomib

      Carfilzomib in combination with cyclophosphamide and etoposide
    5. Drug: Cyclophosphamide
    6. Drug: Carfilzomib

      Carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias

    7. Drug: Etoposide