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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robin Joyce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

BIDMC-W-01-0384-FB

NCT ID:

NCT00052416

Start Date:

October 2002

Completion Date:

January 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401