Completed

A Phase I Dose Escalation Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Pediatric Patients With Advanced Solid Tumors and Lymphomas

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What is being tested

filgrastim

+ exatecan mesylate

BiologicalDrug
Who is being recruted

Brain Diseases+47

+ Brain Neoplasms

+ Central Nervous System Diseases

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorDaiichi Sankyo
Last updated: May 16, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the maximum tolerated dose of exatecan mesylate (DX-8951f) with and without filgrastim (G-CSF) in pediatric patients with advanced solid tumors or lymphomas. Determine the toxic effects, including dose-limiting toxicity, of exatecan mesylate in these patients. Determine the pharmacokinetics of exatecan mesylate in these patients. Determine the recommended dose of exatecan mesylate for phase II study. Determine the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of exatecan mesylate (DX-8951f). Patients are stratified according to prior treatment (minimally treated vs heavily treated). Patients receive exatecan mesylate IV over 30 minutes daily for 5 days. Patients in dose levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

NCT00004212
Principal SponsorDaiichi Sankyo
Last updated: May 16, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsCentral Nervous System DiseasesCerebral Ventricle NeoplasmsCranial Nerve DiseasesCranial Nerve NeoplasmsDNA Virus InfectionsEye DiseasesGliomaHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsOptic Nerve DiseasesPathologic ProcessesPeripheral Nervous System NeoplasmsPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellNeuroectodermal TumorsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOptic Nerve NeoplasmsEpstein-Barr Virus InfectionsDisease AttributesAstrocytomaBurkitt LymphomaLymphomaMedulloblastomaOligodendrogliomaRecurrenceCentral Nervous System NeoplasmsChoroid Plexus NeoplasmsOptic Nerve GliomaDendritic Cell Sarcoma, Interdigitating

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Memorial Sloan-Kettering Cancer Center

New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps

St. Jude Children's Research Hospital

Memphis, United States

Children's Medical Center of Dallas

Dallas, United States

Institute for Drug Development

San Antonio, United States
Completed4 Study Centers