The goal of this clinical research study is to learn if CC-5013, a derivative of thalidomide, can improve myelofibrosis. The safety of CC-5013 in myelofibrosis will also be studied.

Condition	Treatment or Intervention	Phase
Myelofibrosis	Drug: CC-5013	Phase II

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA 1. Diagnosis of myelofibrosis or Philadelphia negative myeloproliferative disorder with myelofibrosis requiring therapy. 2. Disease-free of prior malignancies for > or = 2 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast. 3. ECOG performance status 0 to 3. 4. Total bilirubin < or = 3.0 mg/dL (unless due to tumor) and serum creatinine < or = 3.0 mg/dL (unless due to tumor). 5. Negative pregnancy test in women of childbearing potential within 7 days prior to start of therapy. Women of childbearing potential must be willing to use adequate contraception throughout the study and for 30 days after the last dose of CC-5013. In addition, male patients must be willing to use a condom. 6. Signed informed consent.

EXCLUSION CRITERIA 1. Use of any other experimental drug or therapy within 28 days of therapy, except in cases with rapidly progressive disease and/or recovery from all toxicity from previous therapy (does not apply to growth factors). 2. Platelet count less than 30,000. 3. Known prior clinically relevant hypersensitivity reaction or desquamating rash with thalidomide. 4. Prior therapy with CC-5013.

Deborah Thomas, MD      713-745-4616    debthomas@mdanderson.org

Texas
      M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Deborah Thomas, MD,  Principal Investigator,  M.D. Anderson Cancer Center   

Study ID Numbers:  2003-0648
Record last reviewed:  July 2004
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087672
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16