Purpose

This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Category

IRB Number
20180789HU
NCT Number
NCT03526250
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Anne-Marie Langevin
(210) 567-7460
langevin@uthscsa.edu



Eligibility

Eligible Ages
Between 12 Months and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Advanced Malignant Solid Neoplasm
    2. Recurrent Childhood Ependymoma
    3. Recurrent Ewing Sarcoma
    4. Recurrent Glioma
    5. Recurrent Hepatoblastoma
    6. Recurrent Kidney Wilms Tumor
    7. Recurrent Langerhans Cell Histiocytosis
    8. Recurrent Malignant Germ Cell Tumor
    9. Recurrent Malignant Glioma
    10. Recurrent Medulloblastoma
    11. Recurrent Neuroblastoma
    12. Recurrent Non-Hodgkin Lymphoma
    13. Recurrent Osteosarcoma
    14. Recurrent Peripheral Primitive Neuroectodermal Tumor
    15. Recurrent Rhabdoid Tumor
    16. Recurrent Rhabdomyosarcoma
    17. Recurrent Soft Tissue Sarcoma
    18. Refractory Ependymoma
    19. Refractory Ewing Sarcoma
    20. Refractory Glioma
    21. Refractory Hepatoblastoma
    22. Refractory Langerhans Cell Histiocytosis
    23. Refractory Malignant Germ Cell Tumor
    24. Refractory Malignant Glioma
    25. Refractory Medulloblastoma
    26. Refractory Neuroblastoma
    27. Refractory Non-Hodgkin Lymphoma
    28. Refractory Osteosarcoma
    29. Refractory Peripheral Primitive Neuroectodermal Tumor
    30. Refractory Rhabdoid Tumor
    31. Refractory Rhabdomyosarcoma
    32. Refractory Soft Tissue Sarcoma

      33. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (palbociclib)

      		Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    33. Other: Laboratory Biomarker Analysis

      Correlative studies

    34. Other: Pharmacological Study

      Correlative studies

    35. Drug: Palbociclib

      Given PO

      Other names:

      • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
      • Ibrance
      • PD 0332991
      • PD 332991
      • PD 991
      • PD-0332991

      36.