CC-5013 in Treating Patients With Transfusion-Dependent Low-Risk or Intermediate-Risk Myelodysplastic Syndrome
This study is currently recruiting patients.
Sponsored by: |
Memorial Sloan-Kettering Cancer Center
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Information provided by: |
National Cancer Institute (NCI) |
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
|
Treatment or Intervention |
Phase |
Chronic Myelomonocytic Leukemia previously treated myelodysplastic syndromes de novo myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable secondary myelodysplastic syndromes atypical chronic myeloid leukemia
|
Drug: CC-5013 Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: growth factor antagonist therapy Procedure: non-specific immune-modulator therapy
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Phase II
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MedlinePlus related topics: Bone Marrow Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of CC-5013 in Patients With Transfusion-Dependent Low- or Intermediate-1-Risk Myelodysplastic Syndromes
Further Study Details:
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 above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
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
Surgery
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
Location
and Contact
Information
New York Memorial Sloan-Kettering Cancer Center, New York,
New York,
10021,
United States; Recruiting
Stephen D. Nimer, MD
212-639-7871
Study chairs or principal investigators
Virginia Klimek, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000352173; MSKCC-03109; CELGENE-CC-5013-MDS-002
Record last reviewed:
January 2004
Record first received:
February 10, 2004
ClinicalTrials.gov Identifier:
NCT00077506Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29