Clinical Trial: Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Study of CC-5013 (Lenalidomide NSC# 703813) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome

Brief Summary: This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with relapsed or refractory solid tumors or myelodysplastic syndromes. Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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 populations.

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Maximum tolerated dose of lenolidomide defined as the maximum dose at which fewer than one-third of patients experience DLT [ Time Frame: 28 days ]

Graded using the CTCAE version 3.0.


Original Primary Outcome:

Current Secondary Outcome:

  • Overall response assessed using RECIST criteria [ Time Frame: Up to 30 days after completion of study treatment ]
    A patient will be considered to have responded if she or he demonstrates either a bone marrow or cytogenetic response. Each patient will be classified according to the maximum response of the two criteria, where the classification from maximum to minimum will be: CR, PR or nonresponse.
  • Adverse events defined using the NCI CTCAE version 3.0 [ Time Frame: Up to 30 days after completion of study treatment ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 3, 2005
Date Started: March 2005
Date Completion:
Last Updated: June 10, 2014
Last Verified: December 2012