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

NCT ID: NCT00052416

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2003-01-31

Brief Summary

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.

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.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Robin Joyce, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Countries

United States

Other Identifiers

CDR0000258419

Identifier Type: REGISTRY

Identifier Source: secondary_id

NEDH-W-01-0384-FB

Identifier Type: -

Identifier Source: secondary_id

BIDMC-2001-P-001950

Identifier Type: -

Identifier Source: secondary_id

NCI-V02-1714

Identifier Type: -

Identifier Source: secondary_id

BIDMC-W-01-0384-FB

Identifier Type: -

Identifier Source: org_study_id