RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining the monoclonal antibody rituximab with dexamethasone may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and dexamethasone in treating patients with recurrent or refractory indolent non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma stage III grade II follicular mixed cell lymphoma stage IV grade II follicular mixed cell lymphoma recurrent grade III follicular large cell lymphoma stage III grade I follicular small cleaved cell lymphoma stage IV diffuse small lymphocytic/marginal zone lymphoma stage IV grade III follicular large cell lymphoma Waldenstrom's Macroglobulinemia recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma stage IV grade I follicular small cleaved cell lymphoma stage III diffuse small lymphocytic/marginal zone lymphoma stage III grade III follicular large cell lymphoma	Drug: dexamethasone  Drug: rituximab	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with recurrent or refractory indolent non-Hodgkin's lymphoma.

II. Determine the objective tumor response rate and duration of response at 2 months after initiation of therapy, and the percentage of patients with progressive disease.

III. Determine the maximum response, duration of response, and progression free interval for patients who have not progressed after 4 weeks of therapy.

IV. Determine the failure-free and overall survival of these patients on this regimen.

V. Compare the response rate and survival rates to results for similar patients (historical and concurrent) who have received 4 weeks of rituximab without dexamethasone, and patients who did not receive maintenance rituximab.

PROTOCOL OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22 for one course.

Two months after initiating treatment, patients are evaluated for disease progression. Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months.

Patients are followed every 3 months for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage III or IV, recurrent or refractory, indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A (small cell lymphocytic); Working Group Formulation B, C, and D (follicular)
• Must have relapsed after prior chemotherapy
• At least 1 lymph node or visceral lesion at least 2 cm in diameter

--Prior/Concurrent Therapy--

• Biologic therapy: No prior monoclonal antibody therapy for lymphoma (e.g., rituximab)
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: No other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock)
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Lymphocyte count less than 5,000/mm3
• Hepatic: Not specified
• Renal: Not specified
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active infection; HIV negative; No hepatitis B or C; No concurrent life threatening condition

California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States
Indiana
      Cancer Care Center for Southern Indiana, Bloomington,  Indiana,  47403,  United States
Texas
      St. Joseph Regional Cancer Center, Bryan,  Texas,  77802,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

Study ID Numbers:  CDR0000066756; CBRG-9805; NCI-V98-1492
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003663
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08