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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104962 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: lenalidomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of CC-5013 (Lenalidomide, NSC#703813, IND #70116) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome |
Estimated Enrollment: | 24 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Histologically confirmed solid tumor
Myelodysplastic syndromes (MDS)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Stacey L. Berg, MD | Texas Children's Cancer Center |
Investigator: | Darrell J. Yamashiro, MD, PhD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000413700, COG-ADVL0319, NCI-06-C-0052, NCI-P6553 |
Study First Received: | March 3, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00104962 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified childhood solid tumor, protocol specific de novo myelodysplastic syndromes refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia |
previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory cytopenia with multilineage dysplasia childhood myelodysplastic syndromes |
Leukemia Preleukemia Anemia, Refractory Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes |
Lenalidomide Anemia Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Refractory Anemia |
Neoplasms by Histologic Type Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions |
Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Bone Marrow Diseases |