Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia

September 21, 2010 updated by: Boston Medical Center

CC-1088 Therapy for Chronic Lymphocytic Leukemia: A Phase I/II Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of CC-1088 in treating patients who have chronic lymphocytic leukemia that has not responded to previous therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

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

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Study Chair: Timothy J. Ernst, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

May 3, 2004

First Posted (Estimate)

May 4, 2004

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

May 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068104
  • BUMC-5092
  • NCI-V00-1603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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