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DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
This study has been completed.
Study NCT00004212   Information provided by National Cancer Institute (NCI)
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes

January 28, 2000
February 6, 2009
September 1999
 
 
 
Complete list of historical versions of study NCT00004212 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase I
Interventional
Treatment
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Biological: filgrastim
  • Drug: exatecan mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004212
 
CDR0000067330, DAIICHI-8951A-PRT013, MSKCC-99071, UTHSC-9895011445, NCI-V99-1573
Daiichi Sankyo Inc.
 
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
National Cancer Institute (NCI)
April 2004

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