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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Thalidomide

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