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Raltitrexed in Treating Children With Refractory Acute Leukemia
This study has been completed.
Sponsors and Collaborators: Pediatric Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003528
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia.


Condition Intervention Phase
Leukemia
Drug: raltitrexed
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: ICI D1694
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of Tomudex in Children With Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1998
Detailed Description:

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.

PROJECTED ACCRUAL: This study will accrue 8 patients per year, for a total of approximately 30 patients.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: 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

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants) Life expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 5 times normal Renal: Normal creatinine for age OR GFR at least 70 mL/min Other: No significant systemic illness such as infection No significant third space fluid collections Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: 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 Chemotherapy: At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: 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 Surgery: Not specified Other: No other concurrent anticancer therapy or investigational agents No concurrent nonsteroidal anti-inflammatory agents

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003528

  Show 30 Study Locations
Sponsors and Collaborators
Pediatric Oncology Group
Investigators
Study Chair: Steven D. Weitman, MD, PhD University of Texas
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066575, POG-9779
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003528  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia

Study placed in the following topic categories:
Folic Acid
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Acute myelogenous leukemia
Raltitrexed
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009