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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: April 2004

Detailed Description

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.

Interventions

  • Biological: filgrastim
  • Drug: exatecan mesylate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert L. DeJager, MD, FACP, Study Chair, Daiichi Sankyo

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.