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DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004212
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific Biological: filgrastim Drug: exatecan mesylate Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: 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
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 21 and under at diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks


  • Absolute neutrophil count at least 750/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 8.5 g/dL


  • 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)


  • Creatinine no greater than 1.5 times ULN OR
  • GFR at least 70 mL/min


  • 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


Biologic therapy:

  • Recovered from prior immunotherapy


  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • 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


  • See Disease Characteristics
  • Recovered from prior surgery


  • No other concurrent antitumor therapy
  • No concurrent drugs that induce or inhibit CYP3A enzyme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004212

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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
Sponsors and Collaborators
Daiichi Sankyo, Inc.
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Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00004212     History of Changes
Other Study ID Numbers: CDR0000067330
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012
Keywords provided by Daiichi Sankyo, Inc.:
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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents