NCT00004212

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

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

September 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

4.6 years

First QC Date

January 28, 2000

Last Update Submit

May 15, 2012

Conditions

Brain and Central Nervous System TumorsLymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomachildhood craniopharyngiomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomachildhood central nervous system germ cell tumorunspecified childhood solid tumor, protocol specificstage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomachildhood high-grade cerebral astrocytomachildhood oligodendrogliomachildhood choroid plexus tumorstage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomauntreated childhood brain stem gliomarecurrent childhood brain stem gliomauntreated childhood supratentorial primitive neuroectodermal tumorrecurrent childhood supratentorial primitive neuroectodermal tumoruntreated childhood cerebellar astrocytomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomauntreated childhood medulloblastomarecurrent childhood medulloblastomauntreated childhood visual pathway and hypothalamic gliomarecurrent childhood visual pathway and hypothalamic gliomanewly diagnosed childhood ependymomarecurrent childhood ependymoma

Interventions

filgrastimBIOLOGICAL
exatecan mesylateDRUG

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumors, including brain tumors and lymphomas, that have failed standard therapy (surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no standard therapy exists * Histology requirement waived for brain stem gliomas PATIENT CHARACTERISTICS: Age: * 21 and under at diagnosis Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 750/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 8.5 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases) Renal: * Creatinine no greater than 1.5 times ULN OR * GFR at least 70 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * No history of severe or life-threatening hypersensitivity to camptothecin analogs * HIV negative * No other concurrent severe or uncontrolled medical illness * No systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior extensive radiotherapy involving cranial, whole pelvic, or at least 25% of bone marrow reserve * Recovered from prior radiotherapy * Concurrent localized radiotherapy for pain allowed Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No other concurrent antitumor therapy * No concurrent drugs that induce or inhibit CYP3A enzyme

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

Sponsors & Collaborators

Study Sites (4)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245-3217, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaRecurrenceAstrocytomaOligodendrogliomaChoroid Plexus NeoplasmsBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingMedulloblastomaOptic Nerve GliomaFamilial ependymoma

Interventions

Filgrastimexatecan

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCerebral Ventricle NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosisNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(4)