Clinical Trials /

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

NCT02796261

Description:

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.

Related Conditions:
  • Anaplastic Astrocytoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
  • Official Title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: OT-15-001
  • NCT ID: NCT02796261

Conditions

  • Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma

Interventions

DrugSynonymsArms
EflornithineDFMOEflornithine + Lomustine
LomustineCCNU, CeeNUEflornithine + Lomustine
LomustineCCNU, CeeNULomustine

Purpose

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.

Detailed Description

      This study will consist of 4 study periods of up to 50 months in total, consisting of:

      Screening Period - A maximum screening duration of 4 weeks.

      Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

      End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

      Follow-Up Period - Up to 24 months.

      A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either
      eflornithine + lomustine or lomustine alone.
    

Trial Arms

NameTypeDescriptionInterventions
Eflornithine + LomustineExperimentalEflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
  • Eflornithine
  • Lomustine
LomustineActive ComparatorLomustine dosed every 6 weeks
  • Lomustine

Eligibility Criteria

        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.

          -  Unequivocal evidence of first AA tumor progression or recurrence ≤ 3 months prior to
             randomization based on MRI criteria for tumor progression using enlarging Gd-contrast
             enhancement and/or T2 hyperintensity. 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.

          -  First tumor progression or recurrence following surgical resection or biopsy, if
             resection is not feasible, 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,
             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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Orbus Therapeutics, Inc.

Trial Keywords

  • Anaplastic Astrocytoma
  • Grade 3 Glioma
  • Glioma
  • Eflornithine
  • Brain Cancer
  • Brain Tumor
  • Neuro-oncology
  • Progressive Anaplastic Astrocytoma
  • Recurrent Anaplastic Astrocytoma
  • Progressive Glioma
  • Recurrent Glioma
  • Malignant Glioma
  • Progressive Brain Tumor
  • Recurrent Brain Tumor

Last Updated

October 25, 2017