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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004212 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: filgrastim Drug: exatecan mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Study Start Date: | September 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105-2794 | |
United States, Texas | |
Children's Medical Center of Dallas | |
Dallas, Texas, United States, 75235 | |
Institute for Drug Development | |
San Antonio, Texas, United States, 78245-3217 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000067330, DAIICHI-8951A-PRT013, MSKCC-99071, UTHSC-9895011445, NCI-V99-1573 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004212 History of Changes |
Health Authority: | United States: Federal Government |
childhood infratentorial ependymoma childhood supratentorial ependymoma childhood craniopharyngioma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma childhood central nervous system germ cell tumor unspecified childhood solid tumor, protocol specific stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor stage III childhood small noncleaved cell lymphoma |
stage III childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma untreated childhood brain stem glioma recurrent childhood brain stem glioma untreated childhood supratentorial primitive neuroectodermal tumor recurrent childhood supratentorial primitive neuroectodermal tumor untreated childhood cerebellar astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma untreated childhood medulloblastoma recurrent childhood medulloblastoma untreated childhood visual pathway and hypothalamic glioma |
Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Hodgkin Lymphoma, Childhood DX 8951 Central Nervous System Neoplasms Lymphoblastic Lymphoma Ependymoma Craniopharyngioma Neuroepithelioma Glioma Lymphoma, Large-cell Hodgkin Disease Lymphoma Nervous System Neoplasms |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Astrocytoma Hodgkin's Disease Small Non-cleaved Cell Lymphoma Recurrence Neuroectodermal Tumors Lymphatic Diseases Brain Stem Glioma, Childhood Medulloblastoma Oligodendroglioma Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms DX 8951 |
Pharmacologic Actions Lymphatic Diseases Neoplasms Neoplasms by Site Therapeutic Uses Lymphoproliferative Disorders Lymphoma Antineoplastic Agents, Phytogenic Nervous System Neoplasms |