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.

January 28, 2000
January 27, 2003
May 16, 2012
September 1999
April 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004212 on Archive Site
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DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
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

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.


  • 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.

Phase 1
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Biological: filgrastim
  • Drug: exatecan mesylate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2004
April 2004   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
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Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP