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A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a DEL (5q) Cytogenetic Abnormality


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a DEL (5q) Cytogenetic Abnormality


OBJECTIVES:

Primary

- Determine the efficacy of CC-5013, in terms of hematological improvement, in patients
with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic
syndromes and a del(5)(q31q33) cytogenetic abnormality.

Secondary

- Determine the safety of this drug in these patients.

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

Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated
with a del(5)(q31q33) cytogenetic abnormality

- Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q-
syndrome) OR may be associated with other cytogenetic abnormalities

- Red blood cell (RBC) transfusion-dependent anemia defined as having received at least
2 units of RBCs within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 500/mm^3

- Platelet count at least 50,000/mm^3

- No clinically significant anemia due to iron, B_12, or folate deficiency, autoimmune
or hereditary hemolysis, or gastrointestinal bleeding

- If marrow aspirate not evaluable for storage iron, the following criteria must be
met:

- Transferrin saturation at least 20%

- Serum ferritin at least 50 ng/mL

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- AST and ALT no greater than 3.0 times upper limit of normal

Renal

- Creatinine no greater than 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 (blistering) from thalidomide

- No other serious medical condition, laboratory abnormality, or psychiatric illness
that would preclude study participation or giving informed consent or confound study
results

- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior CC-5013

- More than 7 days since prior hematopoietic growth factors

- No concurrent epoetin alfa for MDS

Chemotherapy

- More than 28 days since prior experimental or standard chemotherapy for MDS

- No concurrent chemotherapy for MDS

Endocrine therapy

- More than 28 days since prior chronic use (greater than 2 weeks in duration) of more
than physiologic doses of corticosteroids

- No concurrent androgens for MDS

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 28 days since prior experimental or standard immunosuppressive or
cytoprotective agents for MDS

- More than 28 days since other prior experimental or standard drugs or therapy for MDS

- No other concurrent investigational agents for MDS

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stephen D. Nimer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000343384

NCT ID:

NCT00074126

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Congenital Abnormalities
  • Chromosome Aberrations
  • Chromosome Disorders
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021