Clinical trial · Interventional
Raltitrexed in Treating Children With Refractory Acute Leukemia
A Phase I Trial of Tomudex in Children With Leukemia
NCT00003528CI-TRIAL-00008914completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: raltitrexed
Primary outcomes (1)
- measure
- MTD based on incidence of DLT graded according to CTC version 2.0
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.