UCSF BTC Clinical Trials

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

 

Summary

This clinical trial tests the safety and efficacy of eflornithine in combination with lomustine (compared to lomustine alone) in treating patients with recurrent anaplastic astrocytoma (AA).

Eflornithine is a drug that inhibits ODC, a protein that is required for polyamine synthesis. Polyamines are essential for stabilizing DNA, and thus proper cell growth and division. This suggests that eflornithine may be effective in inhibiting cell growth and division.

This Phase III study evaluates how well eflornithine works in combination with lomustine, a chemotherapy drug that is already approved for use in patients with brain tumors. Lomustine (also called CCNU) works by interfering with a cell’s DNA and inhibiting further cell division. Eligible participants will be randomized into the following groups:    

  • Experimental Group: Elfornithine + lomustine
  • Active Comparator: Lomustine only

 

Inclusion Criteria
  1. Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
  2. 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.
  3. First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, external beam radiation therapy (EBRT) and temozolomide chemotherapy.
  4. Completion of EBRT ≥ 6 months prior to randomization.
  5. A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if
    1. pathology review confirms AA, and
    2. post-surgical MRI demonstrates measurable tumor on T2/FLAIR.
  6. Karnofsky Performance Status (KPS) score of ≥ 70.

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

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

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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