NCT00002510

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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of etoposide plus radiation therapy followed by peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1992

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1992

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

August 23, 2004

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

9.2 years

First QC Date

November 1, 1999

Last Update Submit

September 30, 2010

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemiarecurrent small lymphocytic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphoma

Interventions

filgrastimBIOLOGICAL
cyclophosphamideDRUG
etoposideDRUG
mesnaDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Pathologically confirmed non-Hodgkin's lymphomas of the following histologic subtypes: Small lymphocytic Follicular small cleaved cell Follicular mixed cell Follicular large cell (relapsed) Disease in first, second, or third partial remission (25% shrinkage in cross-sectional area of measurable disease) or first, second, or subsequent relapse required Transformed non-Hodgkin's lymphoma eligible, i.e., low-grade lymphoma subsequently transformed to intermediate- or high-grade lymphoma No lymphosarcoma cell leukemia PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: Karnofsky 80-100% Hematopoietic: WBC at least 5,000/mm3 (polys at least 2,000/mm3) Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times normal Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: LVEF at least 50% Pulmonary: FVC greater than 1.5 liters FEV1 greater than 1.2 liters MVV greater than 50 liters DLCO greater than 12 mL/min pO2 greater than 70 mm Hg on room air Other: No other serious psychiatric, neurologic, or medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Less than 3,500 cGy prior irradiation to the mediastinum, lungs, or spinal cord 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)

Temple University Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Follicular

Interventions

FilgrastimCyclophosphamideEtoposideMesnaPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Thomas R. Klumpp, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 23, 2004

Study Start

April 1, 1992

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

US(1)