NCT00002481

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1990

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 29, 2004

Completed
Last Updated

December 18, 2013

Status Verified

May 1, 2001

First QC Date

November 1, 1999

Last Update Submit

December 17, 2013

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

cisplatinDRUG
cyclophosphamideDRUG
cytarabineDRUG
dexamethasoneDRUG
etoposideDRUG
autologous bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven or unequivocal radiologic evidence of non-Hodgkin's lymphoma that has relapsed or is refractory after first-line chemotherapy Unequivocal radiologic evidence of relapse defined as the presence of enlarged (at least 2 cm diameter) lymph nodes by CT scan or lymphangiogram Biopsy of accessible lymph nodes to confirm relapse encouraged Low-, intermediate-, or high-grade disease Normal bilateral bone marrow biopsy at time of bone marrow collection required (cellularity at least 20% and no histologic evidence of tumor) History of marrow involvement allowed if present marrow is histologically normal No disease progression in a previously irradiated site A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 16 and over Performance status: CALGB 0-2 Karnofsky 70-100% Life expectancy: More than 2 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times normal SGOT and SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction normal by MUGA scan No uncontrolled or severe cardiovascular disease, including the following: Myocardial infarction within the past 6 months Congestive heart failure Symptomatic angina (despite optimal medical management) Life-threatening arrhythmia or hypertension Pulmonary: Pulmonary function tests (DLCO and spirometry) greater than 60% predicted Other: HIV negative No serious organ dysfunction (unless caused by lymphoma) No active bacterial, viral, or fungal infection No active peptic ulcer disease No uncontrolled diabetes mellitus No other malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No other serious medical or psychiatric illness that would preclude study Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior nitrosourea allowed if cumulative dose no more than 600 mg/m2 Prior bleomycin allowed if cumulative dose no more than 300 units/m2 Prior doxorubicin allowed if cumulative dose no more than 450 mg/m2 No prior high-dose etoposide (more than 1,800 mg/m2) No prior high-dose cyclophosphamide (more than 100 mg/kg) No chemotherapy within 4 weeks (no melphalan, nitrosourea, or mitomycin within 6 weeks) prior to bone marrow collection No prior salvage therapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to liver or lung Prior other radiotherapy allowed if doses do not exceed the following limits: 1,400 cGy to the mediastinum 1,400 cGy to the whole abdomen 4,000 cGy to the CNS Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CisplatinCyclophosphamideCytarabineDexamethasoneEtoposideRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicGlucosidesGlycosidesCarbohydratesTherapeutics

Study Officials

  • Robert F. Taylor, MD

    St. Luke's Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 29, 2004

Study Start

March 1, 1990

Last Updated

December 18, 2013

Record last verified: 2001-05

Locations

US(1)