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Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104962
  Purpose

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

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose and recommended phase II dose as measured by CTCAE v3 at end of course 1 [ Designated as safety issue: Yes ]
  • Toxicities measured by CTCAE v3 [ Designated as safety issue: Yes ]
  • Pharmacokinetics as assessed at end of course 1 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I antitumor activity as measured by response rate at the end of each course [ Designated as safety issue: No ]
  • Feasibility in pediatric patients with relapsed or refractory myelodysplastic syndromes as measured by CTCAE v3 [ Designated as safety issue: No ]
  • Antitumor activity [ Designated as safety issue: No ]
  • Immunologic changes as assessed at end of course 1 [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2005
Estimated Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and recommended phase II dose of lenalidomide in pediatric patients with relapsed or refractory solid tumors.
  • Determine the toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

Secondary

  • Determine, preliminarily, the feasibility of administering this drug to pediatric patients with relapsed or refractory myelodysplastic syndromes.
  • Determine, preliminarily, the antitumor activity of this drug in both patient populations.
  • 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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 1 to 21

Performance status

  • Karnofsky 50-100% (for patients > 10 years of age)
  • Lansky 50-100% (for patients ≤ 10 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3 (for patients with solid tumors)
  • Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)

    • Only patients with MDS may receive transfusions to support platelet counts
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 110*
  • Albumin ≥ 2 g/dL NOTE: *For purposes of this study, the ULN for SGPT is 45 U/L

Renal

  • Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min OR
  • Creatinine based on age as follows:

    • Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age)
    • Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age)
    • Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age)
    • Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age)

Cardiovascular

  • No parent or sibling with a known history of venous thrombosis before the age of 50 OR arterial thrombosis before the age of 40
  • No thromboembolic event except catheter-related thrombosis

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  • Body surface area ≥ 0.4m^2
  • No uncontrolled infection
  • No active graft-vs-host disease from prior stem cell transplant or rescue

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 1 week since prior biologic agents
  • At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim)
  • At least 3 months since prior stem cell transplant or rescue (without total body irradiation [TBI])
  • Prior thalidomide allowed
  • No other concurrent immunotherapy
  • No other concurrent biologic therapy

Chemotherapy

  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent dexamethasone allowed provided the dose has been either decreasing or stable for the past 7 days

Radiotherapy

  • See Biologic therapy
  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative (small port) radiotherapy
  • At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent investigational drugs or agents
  • No other concurrent anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104962

  Show 23 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Stacey L. Berg, MD Texas Children's Cancer Center
Investigator: Darrell J. Yamashiro, MD, PhD Herbert Irving Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Refractory anemia
Myelodysplastic Syndromes
Myelodysplasia
Lenalidomide
Anemia
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009