ADVL1314 - A Phase I Study of Eribulin Mesylate in Solid Tumors

ADVL1314 - A Phase I Study of Eribulin Mesylate, A Novel Microtubule Targeting Chemotherapeutic Agent in Children with Refractory or Recurrent Solid Tumors (Excluding CNS), Including Lymphomas

Diseases

Patients must have recurrent or refractory solid tumors or lymphomas, excluding CNS tumors. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.

Description

Eribulin mesylate is a novel anti-mitotic agent that is a synthetic analog of halichondrin B, designed to inhibit microtubule growth and overcome some of the tumor resistance and toxicity limitations of currently employed vinca alkaloids. Patients will receive eribulin mesylate intravenously on days 1 and 8 of a 21-day cycle. Pharmacokinetic blood draws are also required during the first week of therapy. Therapy may continue in the absense of disease progression or unacceptable toxicity.

Eligibility Criteria

  • Patients must be between 12 months and 18 years of age. A separate cohort will enroll patients between 6 and 12 months at one dose level lower.
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
  • Patients must be fully recovered and have the appropriate waiting period from any surgical procedures.
  • Must have adequate organ function as evidenced by laboratory criteria, EKG, and ECHO.
  • Patients must not have known bone marrow involvement.
  • Patients receiving corticosteroids must be on a stable or decreasing dose for at least 7 days prior to enrollment.
  • Must not be receiving drugs that prolong the QTc interval.
  • Must not have received prior therapy with eribulin mesylate.
  • Must not have a hypersensitivity to excipients of study drug, which include ethanol, hydrochloric acid, sodium hydroxide and water.
  • Must not have a prior history of viral hepatitis or have an uncontrolled infection requiring treatment.
  • Patients with > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy are not eligible.
  • Patients with known congestive heart failure, congenital long QT syndrome, or bradyarrhythmias are not eligible.
  • Patients with primary CNS tumors or a prior history of or known metastatic CNS disease are not eligible.
  • Must not have received a prior solid organ transplantation.

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.