|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003528 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Raltitrexed in Treating Children With Refractory Acute Leukemia | ||||
| Official Title ICMJE | A Phase I Trial of Tomudex in Children With Leukemia | ||||
| Brief Summary | 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. |
||||
| 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. |
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE | Drug: raltitrexed | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
||||
| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003528 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066575, POG-9779 | ||||
| Study Sponsor ICMJE | Pediatric Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2002 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||