RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of etoposide in treating patients with relapsed non-Hodgkin's lymphoma.

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

Further Study Details: 

OBJECTIVES: I. Evaluate the response rate and response duration in patients with relapsed non-Hodgkin's lymphoma when treated with daily oral etoposide. II. Describe the toxic effects of daily oral etoposide in these patients. III. Monitor etoposide trough levels and determine whether etoposide concentrations correlate with age, response, and toxicity.

PROTOCOL OUTLINE: Patients receive oral etoposide daily for 21 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients in complete or partial remission receive 2 courses past best response (minimum 6 courses). Patients with stable disease after 3 courses may be removed from study. Patients are followed every 6 months for 2 years, then annually for survival.

PROJECTED ACCRUAL: Approximately 97 patients will be accrued for this study over 2 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically documented non-Hodgkin's lymphoma; Needle or core biopsy not acceptable as sole means of diagnosis; No mantle cell or transformed lymphoma
• One of the following International Working Formulation (IWF) histologic subtypes required: Small lymphocytic with absolute lymphocytic count less than 5,000 (IWF A); Follicular, predominately small cleaved cell (IWF B); Follicular, mixed (IWF C); Follicular, large cell (IWF D); Diffuse, small cleaved cell (IWF E); Diffuse, mixed (IWF F); Diffuse, large cell (IWF G); Large cell, immunoblastic (IWF H)
• Recurrent or refractory disease treated with no more than 4 prior chemotherapy regimens; Rebiopsy of a node at first relapse recommended; Prior etoposide (oral or intravenous) allowed if given for no more than 5 days every 3 weeks; The following are considered 1 prior therapy each: Identical drugs given on 2 different schedules Bone marrow transplant preparative regimen (single cycle of chemotherapy used solely to mobilize peripheral blood stem cells considered part of preparative regimen)
• Ineligible for protocol CLB-9551 (aminocamptothecin)
• Measurable disease by physical exam or imaging study required; Indicator lesion larger than 1 x 1 cm; No prior radiotherapy to indicator lesion unless progression clearly documented The following are not considered measurable: Barium study; Ascites or pleural effusions; Bony disease; Bone marrow involvement
• No known parenchymal or leptomeningeal CNS disease; Lumbar puncture not required prior to study

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (3 weeks for nitrosoureas, melphalan, or mitomycin)
• Endocrine therapy: No concurrent corticosteroids except for physiologic replacement
• Radiotherapy: At least 3 weeks since prior radiotherapy
• Surgery: Not specified
• Other: No other concurrent investigational agent

--Patient Characteristics--

• Age: Not specified
• Performance status: CALGB 0-2
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times normal
• Renal: Creatinine no greater than 1.5 times normal
• Other: HIV negative (testing required for patients at risk); No uncontrolled infection; No other serious medical condition that would interfere with evaluation of study agent; No psychiatric condition that would preclude protocol completion or informed consent; No second malignancy within 5 years except curatively treated: Basal cell skin cancer; Cervical cancer; Not pregnant or nursing; Adequate contraception required of fertile patients

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
New Jersey
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States
North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

Study chairs or principal investigators

Nancy Bartlett,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000065180; CLB-9650
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002880
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08