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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00052416

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Drug: thalidomide	Phase 1

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 Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401