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Raltitrexed in Treating Children With Refractory Acute Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003528
First received: November 1, 1999
Last updated: January 15, 2013
Last verified: January 2013

November 1, 1999
January 15, 2013
September 1998
June 2002   (final data collection date for primary outcome measure)
MTD based on incidence of DLT graded according to CTC version 2.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003528 on ClinicalTrials.gov Archive Site
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Raltitrexed in Treating Children With Refractory Acute Leukemia
A Phase I Trial of Tomudex in Children With Leukemia

Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia.

II. Determine the incidence and severity of other toxic effects of this regimen in these patients.

III. Determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase II studies.

IV. Determine the pharmacokinetics of this regimen in these patients. V. Determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics.

VI. Evaluate the antitumor activity of raltitrexed against recurrent leukemia.

OUTLINE: This is a dose escalation study.

Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.

In the absence of dose-limiting toxicity (DLT) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of raltitrexed on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.

Patients are followed every 6 months for 4 years, then annually thereafter.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
Drug: raltitrexed
Given IV
Other Names:
  • D1694
  • ICI-D1694
  • TDX
  • Tomudex
Experimental: Arm I
Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.
Intervention: Drug: raltitrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
June 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
  • No CNS leukemia
  • No solid tumors
  • Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
  • Life expectancy: At least 8 weeks
  • Bilirubin less than 1.5 mg/dL
  • SGPT less than 5 times normal
  • Normal creatinine for age OR GFR at least 70 mL/min
  • No significant systemic illness such as infection
  • No significant third space fluid collection
  • Not pregnant or nursing
  • Recovered from acute toxic effects of prior immunotherapy
  • At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
  • At least 10 days since prior biologic therapy
  • At least 1 week since prior growth factors
  • At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
  • No concurrent steroids
  • Recovered from acute toxic effects of all prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 6 months since prior substantial bone marrow radiation
  • No other concurrent anticancer therapy or investigational agents
  • No concurrent nonsteroidal anti-inflammatory agents
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00003528
NCI-2012-01839, 9779, U01CA097452, CDR0000066575
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Steven D. Weitman Swiss Pediatric Oncology Group - Geneva
National Cancer Institute (NCI)
January 2013

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