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Clinical Trial 18778

Cancer Type:
Interventions:Lomustine (CeeNU); eflornithine

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Peter Forsyth

Overview

Study Title

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Summary

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Objective

The primary objectives of this study are to demonstrate superiority in overall survival (OS) and comparable safety when eflornithine is added to lomustine compared to lomustine alone in patients with anaplastic astrocytoma (AA) that progress/recur after irradiation and adjuvant temozolomide chemotherapy. The secondary objectives of this study are to determine: - Progression-free survival (PFS). - The objective response rate (ORR). - Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria. - The OS rate at 18 months (OS-18). The exploratory objectives of this study are: - To determine relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples (i.e., p53 mutation, deletion of chromosomes 1p and 19q, IDH1 mutations, ATRX mutation, Mib-1 labeling index, MGMT promoter methylation). - To determine steady-state plasma pharmacokinetics (PK) for eflornithine in patients within 2 weeks of initial dosing.

Inclusion Criteria

  • Participants must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Surgical or biopsy-proven diagnosis of World Health Organization (WHO) grade 3 anaplastic astrocytoma (AA).
  • Unequivocal evidence of first AA tumor progression or recurrence equal to or less than 3 months prior to randomization based on MRI criteria for tumor progression using enlarging Gd-contrast enhancement and/or T2 hypersensitivity. Patients with non-measurable Gd contrast enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or histopathological confirmation of AA per standard of care procedures is obtained within 4 weeks prior to randomization.
  • First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, external beam radiation therapy (EBRT) and temozolomide chemotherapy.
  • 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, b) post-surgical MRI demonstrates measurable tumor on T2/FLAIR, and c) MRI performed after surgery is within 4 weeks prior to randomization.
  • Karnofsky Performance Status (KPS) score of > 70.

    • Exclusion Criteria

  • Potential participants 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 participant unsuitable for the study.
  • Pregnant or breastfeeding.

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