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Related Experiment Video

Updated: Jul 15, 2026

HPLC-based Assay to Monitor Extracellular Nucleotide/Nucleoside Metabolism in Human Chronic Lymphocytic Leukemia Cells
11:29

HPLC-based Assay to Monitor Extracellular Nucleotide/Nucleoside Metabolism in Human Chronic Lymphocytic Leukemia Cells

Published on: July 20, 2016

Phase I study of lenalidomide in solid tumors.

Antonius A Miller1, Doug Case, Michele Harmon

  • 1Wake Forest University, Comprehensive Cancer Center, Winston-Salem, NC 27157, USA. aamiller@wfubmc.edu

Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer
|May 3, 2007
PubMed
Summary

This Phase I study determined the tolerable dose of lenalidomide for solid tumors. The recommended dose is 25 mg/day for 4 weeks followed by a 2-week rest, with manageable toxicity.

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HPLC-based Assay to Monitor Extracellular Nucleotide/Nucleoside Metabolism in Human Chronic Lymphocytic Leukemia Cells
11:29

HPLC-based Assay to Monitor Extracellular Nucleotide/Nucleoside Metabolism in Human Chronic Lymphocytic Leukemia Cells

Published on: July 20, 2016

Area of Science:

  • Oncology
  • Clinical Pharmacology

Background:

  • Phase I clinical trial investigating lenalidomide in solid tumors refractory to standard treatment.
  • Focus on defining tolerable dose and toxicity profile for a novel dosing schedule.

Purpose of the Study:

  • Determine the maximum tolerated dose (MTD) of lenalidomide.
  • Evaluate the safety and tolerability of lenalidomide.
  • Assess preliminary antitumor activity.

Main Methods:

  • Oral lenalidomide administered at 5, 10, and 25 mg/day in a 4-week on, 2-week off schedule.
  • Dose escalation based on toxicity, with dose-limiting toxicity defined by specific criteria.
  • Eligibility included performance status 0-2 and adequate organ function.

Main Results:

  • Twenty patients enrolled; 12 received 25 mg/day.
  • One dose-limiting toxicity (grade 3 motor neuropathy) observed at 25 mg/day.
  • Generally mild to moderate, reversible hematologic and non-hematologic toxicities.

Conclusions:

  • The recommended Phase II dose for lenalidomide in solid tumors is 25 mg/day.
  • The 4-week on, 2-week off schedule is tolerable with manageable toxicity.
  • Preliminary evidence of antitumor activity, including partial response in one patient.