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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Lymphatic Diseases;   Lymphoma;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Daily Oral Etoposide in Patients With Relapsed Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: November 1996

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

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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005