Open Actively Recruiting

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

About

Brief Summary

This clinical research study is a Phase 3 clinical trial which tests the safety and effectiveness of a study drug to learn whether the study agent works in treating a specific cancer. The purpose of the research study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Safety and how well you can tolerate the drug will be determined on the basis of physical exams, laboratory tests, and questions about any problems you might experience during the study. The background of the study drug Eflornithine: A study drug is one that has not been approved by the U.S. Food and Drug Administration (FDA) or any other government agency. A study drug can only be administered in a research study such as this. Eflornithine is a new study drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any other government agency. Eflornithine is a type of therapy called an ODC inhibitor. Ornithine decarboxylase, or ODC, is an enzyme that is encoded by the ODC gene. It has been shown that ODC promotes tumor cells growth and division. By inhibiting ODC, eflornithine inhibits cell growth and division. Studies have shown that Eflornithine, in combination with other chemotherapy, may help prolong the durability of treatment effect by making it more difficult for the treated tumor cells to start grow again.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult subjects with newly diagnosed with brain tumors that had cleared but have returned.

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation

in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
  • First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
    • Gd-contrast lesion margins are not clearly defined,
    • Gd-contrast lesions are only measurable in one dimension,
    • Gd-contrast lesion has two perpendicular diameters less than 10 mm,
    • Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
    • Recent histopathological confirmation of WHO grade 3 AA
  • Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study

participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
16-000887
Category
Neurology
Oncology
Urology
Contact
Sichen Li
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02796261
For detailed technical eligibility, visit ClinicalTrials.gov.