Clinical trial · Interventional
High-Dose Methotrexate in Treating Young Patients With Solid Tumors
Study to Determine the Maximum Tolerated Time of Infusion for High-Dose Methotrexate, Administered as a Continuous Intravenous Infusion at a Dose of 6g/m² Per 24 Hours of Infusion Time
- 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)
RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| mass spectrometry | Other | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated infusion time for high-dose methotrexate
Secondary outcomes (1)
- measure
- Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven malignancy, including but not limited to, any of the following:
* Patients with MRI findings in keeping with a diffuse intrinsic pontine glioma will be eligible without histological confirmation of tumor type
* Patients with a diagnosis of diffuse intrinsic pontine glioma who are not eligible for the erlotinib hydrochloride phase I study (CCLG-NAG-2005-09)
* Patients with relapsed ependymoma following the CCLG phase II study of intravenous etoposide (CCLG-CNS-2001-4) or prior to this are eligible at the discretion of the physician
* Patients with relapsed osteogenic sarcoma, other soft tissue sarcomas, or other solid tumors may be suitable for this study at the discretion of the physician
* Radiologically evaluable disease without bone marrow involvement
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Lansky performance status (PS) 30-100% (for patients ≤ 12 years of age)
* ECOG PS ≤ 2 (for patients ≥ 13 years of age)
* Life expectancy ≥ 9 weeks
* ANC \> 1,000/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) for age
* Serum total bilirubin normal
* AST or ALT ≤ 2 times ULN
* Glomerular filtration rate ≥ 60 mL/min
* Negative pregnancy test
* Fertile patients must use effective contraception
Exclusion criteria:
* Poor medical risk because of nonmalignant systemic disease or uncontrolled infection
* Concurrent malignancies at other sites
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Prophylactic trimethoprim-sulfamethoxazole must be stopped 1 week prior to methotrexate administration
Exclusion criteria:
* Received chemotherapy or biologic therapy within the past 4 weeks
* Received radiotherapy within the past 6 weeksReferences
Publications (0)
Data not yet available