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Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma



Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

For Condition: Waldenstrom's Macroglobulinemia,recurrent grade III follicular large cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent small lymphocytic lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
NancyBartlett,  Study Chair,  Cancer and Leukemia Group B

University of Minnesota Cancer Center
Minneapolis,  Minnesota,  55455
United States
 

Washington University Barnard Cancer Center
St. Louis,  Missouri,  63110
United States
 

St. Joseph's Hospital and Medical Center
Paterson,  New Jersey,  07503
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065180;  CLB-9650
Study Start Date: November 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002880

Other Recurrent Small Lymphocytic Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

2. Rituximab and Interleukin-2 in Treating Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma That is Refractory to Rituximab

3. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

4. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

5. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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