Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
Etoposide
Etoposide phosphate
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

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

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