Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

June 25, 2013 updated by: Beth Israel Deaconess Medical Center

Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the feasibility, in terms of toxicity and patient compliance, of thalidomide in patients with asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
  • Determine the event-free and progression-free survival of patients treated with this drug.
  • Determine disease response and time to next treatment in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, monthly during study, and at the end of the study.

PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study within 2 years.

Study Type

Interventional

Phase

  • 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, 02215
        • Beth Israel Deaconess Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus

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 confirmed indolent lymphoma or leukemia of one of the following subtypes:

    • Chronic lymphocytic leukemia
    • Follicular center lymphoma (grade I or II)
    • Lymphoplasmacytic lymphoma
    • Marginal zone lymphoma (nodal, extranodal, or splenic)
    • Small lymphocytic lymphoma
    • Waldenstrom's macroglobulinemia
  • Any stage of disease allowed
  • No hairy cell leukemia
  • No T-cell lymphomas
  • No prior treatment for lymphoma/leukemia

  • Considered appropriate for expectant management

    • Must not require cytotoxic therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin greater than 10.0 g/dL
  • Platelet count greater than 75,000/mm^3

Hepatic

  • Bilirubin no greater than 2 times normal
  • AST and ALT no greater than 2 times normal

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No uncontrolled congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No unstable coronary artery disease
  • No myocardial infarction in the past 6 months
  • No serious or uncontrolled arrhythmias
  • No history of thromboembolic disease

Pulmonary

  • No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the past 3 months)

Other

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Not planning to become pregnant in the next 2 years
  • Fertile female patients must use 1 highly effective method and 1 additional effective method of contraception for 1 month prior to, during, and for 1 month after study participation
  • Male patients must use effective barrier contraception during and for 1 month after study participation
  • Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program
  • No contraindications to meeting the requirements of the S.T.E.P.S. program
  • No other prior malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy

  • No poorly controlled diabetes defined by either of the following:

    • Glycosylated hemoglobin greater than 8.0 g/dL
    • Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy)
  • No other concurrent illness that would preclude study therapy

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Study Chair: Robin Joyce, MD, Beth Israel Deaconess 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

October 1, 2002

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIDMC-W-01-0384-FB
  • CDR0000258419 (Registry Identifier: PDQ (Physician Data Query))
  • NEDH-W-01-0384-FB
  • BIDMC-2001-P-001950
  • NCI-V02-1714

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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