NCT00104962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 11, 2014

Status Verified

December 1, 2012

Enrollment Period

4.3 years

First QC Date

March 3, 2005

Last Update Submit

June 10, 2014

Conditions

Childhood Myelodysplastic Syndromesde Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRefractory AnemiaRefractory Anemia With Excess BlastsRefractory Anemia With Ringed SideroblastsRefractory Cytopenia With Multilineage DysplasiaSecondary Myelodysplastic SyndromesUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days

Secondary Outcomes (2)

  • Overall response assessed using RECIST criteria

    Up to 30 days after completion of study treatment

  • Adverse events defined using the NCI CTCAE version 3.0

    Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (lenalidomide)

EXPERIMENTAL

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.

Drug: lenalidomide

Interventions

lenalidomideDRUG

Given orally

Also known as: CC-5013, IMiD-1, Revlimid
Treatment (lenalidomide)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of 1 of the following:
  • Histologically confirmed solid tumor
  • No brain tumors
  • Myelodysplastic syndromes (MDS)
  • No refractory anemia with excess blasts in transformation or other forms of acute myeloid leukemia (AML)
  • No FAB diagnosis of refractory anemia with excess blasts in transition and other forms of AML
  • Newly diagnosed MDS with chromosome 5q abnormalities
  • Relapsed or refractory disease including relapse after stem cell transplantation
  • Measurable or evaluable disease (solid tumor patients only)
  • No known curative or life-prolonging therapy exists
  • No bone marrow involvement by tumor (solid tumor patients only)
  • No CNS tumors
  • Performance status - Karnofsky 50-100% (for patients \> 10 years of age)
  • Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
  • Absolute neutrophil count ≥ 1,000/mm\^3 (for patients with solid tumors)
  • +38 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

Related Publications (1)

  • Berg SL, Cairo MS, Russell H, Ayello J, Ingle AM, Lau H, Chen N, Adamson PC, Blaney SM. Safety, pharmacokinetics, and immunomodulatory effects of lenalidomide in children and adolescents with relapsed/refractory solid tumors or myelodysplastic syndrome: a Children's Oncology Group Phase I Consortium report. J Clin Oncol. 2011 Jan 20;29(3):316-23. doi: 10.1200/JCO.2010.30.8387. Epub 2010 Dec 13.

    PMID: 21149673DERIVED

MeSH Terms

Conditions

Anemia, RefractoryAnemia, Refractory, with Excess of Blasts

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stacey Berg

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 11, 2014

Record last verified: 2012-12

Locations

US(1)