B-cell NHL: phase 1/2 results with fenretinide + rituximab

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  • In patients with B-cell non-Hodgkin lymphoma (B-NHL), fenretinide + rituximab (Rituxan) delivered moderate, but durable response with encouraging tolerability.

Why this matters

  • Fenretinide has demonstrated anti-tumor action in preclinical studies.

Study design

  • Phase 1/2 study of fenretinide + rituximab in 32 patients with B-NHLs.
  • In the phase 1 study, fenretinide was initiated at the maximal dose of 900 mg/m2; dose was reduced to 700 mg/m2 pending dose-limiting toxicities.
  • In the phase 2 study, patient received fenretinide at the dose from phase 1 + rituximab 375 mg/m2.
  • De-escalation design in cohorts of 6 patients starting at the maximal dose of 900 mg/mby mouth twice-daily, on days 1-5 followed by a 2-d drug holiday.
  • Funding: National Institutes of Health.

Key results

  • 7 patients treated in phase 1; ...