NCT00004132

Brief Summary

RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

December 10, 1999

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2000

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2007

First QC Date

December 10, 1999

Last Update Submit

June 25, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmOral ComplicationsRadiation Toxicity

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomachildhood Burkitt lymphomarefractory multiple myelomastage 0 chronic lymphocytic leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomastage IV childhood lymphoblastic lymphomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiablastic phase chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesuntreated childhood acute lymphoblastic leukemiaoral complicationsstage IV childhood Hodgkin lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent 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 lymphomaprimary central nervous system non-Hodgkin lymphomadrug/agent toxicity by tissue/organradiation toxicitystage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaanaplastic large cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

filgrastimBIOLOGICAL
paliferminBIOLOGICAL
cyclophosphamideDRUG
etoposideDRUG
ifosfamideDRUG
quality-of-life assessmentPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of Non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma Eligible for total body irradiation plus high dose chemotherapy followed by autologous peripheral blood stem cell transplantation At least 1,500,000 CD34+ cells/kg cryopreserved No prior treatment on this study PATIENT CHARACTERISTICS: Age: 12 to 65 Performance status: Karnofsky 70-100% SWOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1000/mm3 Platelet count greater than 100,000/mm3 If conditioning regimen scheduled soon after apheresis, platelet count of greater than 50,000/mm3 but less than 100,000/mm3 allowed Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class III or IV heart disease Pulmonary: DLCO at least 50% predicted Other: No prior or concurrent second malignancy No active infection or oral mucositis No insulin dependent diabetes mellitus HIV negative No sensitivity to E. coli derived products Not pregnant or nursing Fertile patients must use effective contraception one month before, during, and one month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem cell transplantation, unless undergoing second transplant of a tandem transplant regimen, with no complications after first transplant No concurrent interleukin-11 Chemotherapy: No other concurrent cytotoxic chemotherapy, except intrathecal methotrexate for CNS involvement Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy that would preclude total body irradiation Surgery: Not specified Other: At least 30 days since prior investigational devices or drugs, except Baxter Isolex i column No other concurrent investigational agents No concurrent prophylactic oral cryotherapy during chemotherapy

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellRadiation InjuriesHodgkin DiseaseBurkitt LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast CrisisLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal Zone

Interventions

FilgrastimFibroblast Growth Factor 7CyclophosphamideEtoposideIfosfamideRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersWounds and InjuriesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsFibroblast Growth FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Christos E. Emmanouilides, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 20, 2004

Study Start

January 1, 2000

Study Completion

May 1, 2004

Last Updated

June 26, 2013

Record last verified: 2007-06

Locations

US(1)