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PBTC-029B - A Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

PBTC-029B - A Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Diseases

Patients must have a progressive, recurrent, or refractory low grade glioma, such as pilocytic astrocytoma or optic pathway glioma. Patients must have bi-dimensionally measurable disease.

Description

AZD6244 is an orally available small molecule inhibitor of the MAP kinases MEK1 and 2, which have been shown to play a role in both sporadic and NF-1 associated low grade gliomas. AZD6244 will be given orally twice daily on a continuous basis, divided into 28 day courses. Treatment may continue for up to 26 courses as long as the patient is experiencing stable or improved disease and is not having any unacceptable toxicities.

Eligibility Criteria

  • Patients must be between 3 and 21 years of age with a BSA of at least 0.55m2.
  • Patients must not have received myelosuppressive chemotherapy within the past 3 weeks, biologic agents in past 7 days, or monoclonal antibodies for at least three half lives of the agent.
  • Patients must not have had local irradiation to the primary tumor within 12 months prior to study entry or craniospinal irradiation within 3 months.
  • Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration and neurologically stable.
  • Must be able to swallow capsules.
  • Must have adequate organ function as evidenced by laboratory criteria.
  • Must have serum sodium and potassium within the institutional limits of normal and serum calcium and magnesium above the lower limit of normal.
  • Must have adequate cardiac function based on LVEF and QTc interval.
  • Must have a blood pressure that is less than the 95th percentile for age, height, and gender.
  • Patients cannot have uncontrolled seizures.
  • Cannot have had any previous treatment with a MEK inhibitor or BRAF inhibitor.
  • Cannot have any other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT syndrome) or require any concomitant medications that can prolong the QT interval.

Contact

For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur,RN, MSN, CPNP, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at kamazur@txch.org.