PBTC29: Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

A Phase I and Phase II and Re-treatment Study of AZD6244 for Recurrent or Refractory Low Grade Glioma (PBTC-029)

Categories:

Brain Tumor

Phase I/II

Diseases Treated:

Gliomas

Eligibility Overview:

  • Participant is ≥ 3 but ≤ 21 years of age at registration.
  • Participant has a diagnosis of low grade glioma (Grades I & II) or optic pathway gliomas with clinical and/or radiographic evidence of progression.
  • Participant received last fraction of local irradiation to the primary tumor ≥ 12 weeks prior to registration, or does not apply.

Description

Low grade gliomas are among the most common primary CNS (central nervous system) neoplasms (an abnormal new mass of tissue that serves no purpose) of childhood.

Low-grade gliomas are also classified according to the location of the brain from which they originate. The commonly used therapies are surgery, chemotherapy and radiation. This study will determine the maximum tolerated dose of drug called AZD6244 (selumetinib) in children 12 years or over with gliomas which have returned following radiation and /or chemotherapy.The duration of the study will be four and half years.

Objectives

  • To describe the toxicity profile and define the dose limiting toxicity of AZD6244 in children with recurrent or refractory low-grade glioma.

Eligibility

Inclusion Criteria

  • Participant is ≥ 3 but ≤ 21 years of age at registration.
  • Participant has a diagnosis of low grade glioma (Grades I & II) or optic pathway gliomas with clinical and/or radiographic evidence of progression.
  • Participant must be able to swallow capsules.
  • Participant has fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.
  • Participant received last fraction of local irradiation to the primary tumor ≥ 12 weeks prior to registration, or does not apply.
  • Participant meets other requirements defined in the eligibility portion of the study.
  • Participant is able to perform ordinary tasks and daily activities as defined in the study guidelines.

For current eligibility status of this clinical study, the referring physician and/ or patient’s family may contact St. Jude’s Brain Tumor Coordinator at (901) 595-2544 or (901) 595-4599.

Contact

Ibrahim Qaddoumi, 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

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.