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CC-5013 in Treating Patients With Transfusion-Dependent Low-Risk or Intermediate-Risk Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077506
  Purpose

RATIONALE: CC-5013 may stop the growth of myelodysplastic syndrome by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who have transfusion-dependent low-risk or intermediate-risk myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: lenalidomide
Phase II

MedlinePlus related topics: Blood Transfusion and Donation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Multicenter, Single-Arm, Open-Label Study Of The Efficacy And Safety Of CC-5013 Monotherapy In RBC Transfusion-Dependent Subjects With Myelodysplastic Syndromes

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

Study Start Date: September 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of CC-5013, in terms of hematopoietic improvement, in patients with transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes.

Secondary

  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral CC-5013 once daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 136 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of low- or intermediate-1-risk myelodysplastic syndromes (MDS)

    • No abnormality of chromosome 5 involving a deletion between bands q31 and q33
  • Red blood cell (RBC) transfusion-dependent, defined as having received at least 2 units of RBCs within the past 8 weeks
  • No proliferative (WBC ≥ 12,000/mm^3) chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 500/mm^3
  • Platelet count ≥ 50,000/mm^3
  • No clinically significant anemia due to iron, B_12, or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding* NOTE: *If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be ≥ 20% AND ferritin ≥ 50 ng/mL

Hepatic

  • AST and ALT ≤ 3.0 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL

Renal

  • Creatinine ≤ 2.5 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide
  • No prior grade 3 or greater rash or any desquamation while taking thalidomide
  • No other malignancy within the past 3 years except basal cell or squamous cell cancer or carcinoma in situ of the cervix or breast
  • No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent or participating in the study
  • Able to aspirate bone marrow

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior CC-5013
  • More than 7 days since prior hematopoietic growth factors
  • No concurrent red blood cell hematopoietic growth factors (e.g., epoetin alfa)

Chemotherapy

  • More than 28 days since prior chemotherapy for MDS
  • No concurrent chemotherapy for MDS

Endocrine therapy

  • More than 28 days since prior chronic use (more than 2 weeks) of more than physiologic doses of corticosteroids (dose equivalent to more than 10 mg/day of prednisone)
  • No concurrent corticosteroids except steroids for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
  • No concurrent androgens

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 28 days since prior standard (i.e., immunosuppressive or cytoprotective agents) therapy for MDS
  • More than 28 days since prior experimental therapy
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077506

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Virginia Klimek, MD Memorial Sloan-Kettering 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: CDR0000352173, MSKCC-03109, CELGENE-CC-5013-MDS-002
Study First Received: February 10, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00077506  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia

Study placed in the following topic categories:
Myelodysplastic syndromes
Chronic myelogenous leukemia
Precancerous Conditions
Chronic myelomonocytic leukemia
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplasia
Myelodysplastic Syndromes
Lenalidomide
Myeloproliferative Disorders
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm Metastasis
Myelodysplastic-Myeloproliferative Diseases
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 15, 2009