Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over Other BUMC-5092 NCI-V00-1603, NCT00006097

Objectives

I.  Determine the toxicity of CC-1088 in patients with refractory, 
progressive, B-cell chronic lymphocytic leukemia.

II.  Determine the response rate to this treatment in these patients.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed refractory, progressive, B-cell
chronic lymphocytic leukemia
 Failed prior first line therapy of chlorambucil or fludarabine (or their
  equivalent) 
 Progressive disease as defined by at least one of the following:
  Greater than 50% increase in the sum of the products of at least 2 lymph     
   nodes on two consecutive determinations 2 weeks apart (at least one lymph   
   node must be greater than 2 cm)
  Appearance of new palpable lymph nodes
  At least a 50% increase in size of previously palpable liver or spleen
  Appearance of palpable hepatomegaly or splenomegaly not previously present
  At least a 50% increase in the absolute lymphocyte count to at least         
   5,000/mm3
  Transformation to an aggressive histology (e.g., Richter's or prolymphocytic 
   leukemia)

High risk OR
Intermediate risk with active disease, as defined by the following:
 Greater than 10% weight loss
 Extreme fatigue
 Fevers greater than 100.5 Fahrenheit for greater than 2 weeks without         
  infection
 Night sweats
 Splenomegaly greater than 6 cm
 Lymphadenopathy greater than 10 cm
 Lymphocytosis with a doubling time less than 6 months

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG or Zubrod 0-2

Life expectancy:
 Not specified

Hematopoietic:
 See Disease Characteristics

Hepatic:
 Bilirubin no greater than 2.5 times upper limit of normal (ULN)
 ALT and AST no greater than 2.5 times ULN

Renal:
 Creatinine no greater than 2.0 mg/dL

Other:
 Not pregnant 
 Negative pregnancy test
 Fertile patients must use effective contraception during and for 2 weeks      
  after study

Expected Enrollment

A total of 11-20 patients will be accrued for this study.

Outline

Patients receive oral CC-1088 three times a day for 28 days.  Treatment 
continues in the absence of disease progression or unacceptable toxicity. 

Trial Contact Information

Trial Lead Organizations

Boston University Cancer Research Center

Timothy Ernst, MD, Protocol chair(Contact information may not be current)		Ph: 617-414-1835 Email: ternst@bu.edu

Registry Information
Official Title		CC-1088 Therapy for Chronic Lymphocytic Leukemia: A Phase I/II Trial
Trial Start Date		1999-08-01
Registered in ClinicalTrials.gov		NCT00006097
Date Submitted to PDQ		2000-06-27
Information Last Verified		2001-05-01