PBTC42: Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors

Phase I Study of CDK 4-6 Inhibitor PD-0332991 in Children with Recurrent, Progressive or Refractory Central Nervous System Tumors

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Retinoblastoma protein 1 (Rb1) positive recurrent, progressive, or refractory central nervous system tumors

Eligibility Overview:

  • Participant between four (4) and twenty-one (21) years of age at time of enrollment.
  • Participant has histologically confirmed Rb1 positive recurrent, progressive, or refractory CNS tumor or DIPG.
  • Participant with a neurological deficit that is stable for at least one (1) week prior to enrollment.
  • Participant has received last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to enrollment.
  • Participant has received last fraction of focal irradiation > two (2) weeks prior to enrollment.

Description

This study will be enrolling patients who have a brain tumor that has grown (progressive), come back (recurrent), or has not responded to treatment (refractory). The study has two components; a screening phase and a treatment phase. The purpose of the screening phase is to perform a test on a sample of your tumor which was removed at a time of your previous surgery. The test will determine if the tumor has a specific protein called Rb1. The Rb1 protein requirement is needed to qualify for the second part of the study; the main treatment phase. The Rb1 protein stops malignant (cancer) tumor cells from growing and becoming cancer. During the treatment phase the study participant will receive the experimental medicine called PD-0332991. PD-0332991 has been previously tested in adults only. This study is the first time this drug is being given to children. The study doctor (s) will test different doses of the medicine to determine the maximum dose that can be safely given to children with this type of tumor (cancer). The study hopes to find that PD-0332991 will be a more effective treatment for many types of childhood brain tumors.

Objectives

  • To find the highest dose of PD-0332991 that can be given safely without causing severe side effects.
  • To learn what side effects may occur when PD-033291 is given.
  • To learn how the body handles PD-0332991 by studying the levels of the drug in the blood.

Eligibility

Screen Inclusion

  • Participant between four (4) and twenty-one (21) years of age.
  • Participant has recurrent, refractory, or progressive central nervous system (CNS) tumor.
  • Participant is able to swallow capsules.
  • Participant is willing to provide pre-trial tumor material for Rb1 testing.

Screen Exclusion

  • Participant has low grade glioma.
  • Participant has received > 2 prior chemotherapy regimens and/or focal radiotherapy.
  • Participant has received myeloablative chemotherapy with stem cell rescue.
  • Participant has received craniospinal irradiation.

Treatment Inclusion (among others)

  • Participant between four (4) and twenty-one (21) years of age at time of enrollment.
  • Participant has histologically confirmed Rb1 positive recurrent, progressive, or refractory CNS tumor or DIPG.
  • Participant with a neurological deficit that is stable for at least one (1) week prior to enrollment.
  • Participant has received last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to enrollment.
  • Participant has received last fraction of focal irradiation > two (2) weeks prior to enrollment.

Treatment Exclusion (among others)

  • Participant with low grade glioma.
  • Participant with Rb1 negative tumor.
  • Participant has received myeloablative chemotherapy with stem cell rescue.
  • Participant has received craniospinal irradiation.
  • Participant requires enzyme inducing anti-convulsants to control seizures.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Zsila Sadighi, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Phone: 901-595-2544 or 901-595-4599
Fax: 901-595-6211

OR

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
MS 260
262 Danny Thomas Place
Memphis, TN 38105
Phone: (901) 595-2544
FAX: (901) 595-6211

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.