Clinical trial NCT00052416: Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official title: Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Lymphoma
Keywords: B-cell chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
stage I grade 1 follicular lymphoma
stage III grade 1 follicular lymphoma
stage IV grade 1 follicular lymphoma
contiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
stage I grade 2 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 2 follicular lymphoma
Waldenström macroglobulinemia
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Fletcher Allen Health Care - University Health Center Campus
state: Vermont
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Robin Joyce, MD
role: STUDY_CHAIR
References: