Phase I Study of CC-5013 (Lenalidomide NSC# 703813, IND # 70116) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome
I. Determine the maximum tolerated dose and recommended phase II dose of lenalidomide in
pediatric patients with relapsed or refractory solid tumors.
II. Determine the toxic effects of this drug in these patients. III. Determine the
pharmacokinetics of this drug in these patients.
I. Determine, preliminarily, the feasibility of administering this drug to pediatric
patients with relapsed or refractory myelodysplastic syndromes.
II. Determine, preliminarily, the antitumor activity of this drug in both patient
III. Determine immunologic changes in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
diagnosis (solid tumor vs myelodysplastic syndromes [MDS]).
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days
for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients with solid tumors receive escalating doses of lenalidomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. Patients with MDS receive a fixed
dose (do not undergo dose escalation) of lenalidomide. After completion of study treatment,
patients are followed annually.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenolidomide defined as the maximum dose at which fewer than one-third of patients experience DLT
Graded using the CTCAE version 3.0.
COG Phase I Consortium
United States: Food and Drug Administration
|COG Phase I Consortium||Arcadia, California 91006-3776|