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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    340
  • sponsor
    Orbus Therapeutics, Inc.
Updated on 25 May 2021
karnofsky performance status
MRI
flair
glioblastoma multiforme
temozolomide
astrocytoma
anaplastic astrocytoma
tumor progression
astrocytoma, anaplastic
lomustine
recurrent anaplastic astrocytoma

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.

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 approximately 36 months, or until patient death.

A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Details
Condition Astrocytoma, Glioma, Recurrent Anaplastic Astrocytoma, Gliomas, anaplastic astrocytoma, astrocytoma, anaplastic
Treatment Lomustine, Eflornithine
Clinical Study IdentifierNCT02796261
SponsorOrbus Therapeutics, Inc.
Last Modified on25 May 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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