NCT00003243

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. White blood cells from donors may be able to kill cancer cells in patients who have hematologic cancer that has recurred following bone marrow transplantation. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus infusion of donated white blood cells in treating patients who have hematologic cancer that has recurred after bone marrow transplantation.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

First QC Date

November 1, 1999

Last Update Submit

March 9, 2010

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiaacute undifferentiated leukemiarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomasecondary acute myeloid leukemiapreviously treated myelodysplastic syndromesrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablechildhood myelodysplastic syndromes

Interventions

aldesleukinBIOLOGICAL
filgrastimBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
cyclophosphamideDRUG
etoposideDRUG
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of relapsed or persistent acute leukemia, myelodysplasia, aggressive non-Hodgkin's lymphoma (NHL), or chronic myeloid leukemia in transformed phase (accelerated phase or blast crisis) after allogeneic bone marrow transplantation (BMT) * Aggressive NHL defined as diffuse mixed, diffuse large cell, diffuse small noncleaved cell, and lymphoblastic histologies * No active acute graft versus host disease (GVHD) or extensive chronic GVHD PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-2 Life expectancy: * More than 4 weeks Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No severe psychiatric illness or mental deficiencies PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 6 months since prior allogeneic BMT * No other concurrent interleukin-2 * No other concurrent immunomodulatory medication (e.g., interferon) Chemotherapy: * Not specified Endocrine therapy: * No concurrent steroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent immunosuppressive medication (e.g., cyclosporine) for GVHD

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

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Biphenotypic, AcuteLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative Disorders

Interventions

aldesleukinFilgrastimCyclophosphamideEtoposide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLeukemia, LymphoidLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosis

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 CompoundsGlucosidesGlycosides

Study Officials

  • Ephraim J. Fuchs, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1998

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

US(1)