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Home > "R" Clinical Trials Conditions > Raltitrexed in Treating Children With Refractory Acute Leukemia  Raltitrexed in Treating Children With Refractory Acute Leukemia
Raltitrexed in Treating Children With Refractory Acute Leukemia
For Condition: recurrent childhood acute myeloid leukemia,recurrent childhood acute lymphoblastic leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenWeitman, Study Chair, Pediatric Oncology Group
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Additional Information:
Study ID Numbers: CDR0000066575; POG-9779
Study Start Date: September 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003528
Other Recurrent Childhood Acute Myeloid Leukemia Studies:
1. Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
2. Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
3. Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
4. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
5. STI571 in Treating Patients With Recurrent Leukemia
Related Studies:
Other recurrent childhood acute myeloid leukemia Clinical Trials
Other Kansas Clinical Trials
Other Kansas City Clinical Trials
Raltitrexed in Treating Children With Refractory Acute Leukemia
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