Clinical trial · Interventional
Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Phase I Trial of Escalating High Dose Methotrexate Supported by Glucarpidase to Treat Patients With Primary Central Nervous Lymphoma (PCNSL)
- 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 methotrexate and leucovorin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Glucarpidase may help return the level of methotrexate in the blood to a safe range. Giving high-dose methotrexate together with glucarpidase and leucovorin may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate when given together with glucarpidase and leucovorin in treating patients with newly diagnosed primary central nervous system lymphoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mucositis | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| glucarpidase | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Immediate toxicity (incidence of reactions to glucarpidase) as determined by the NCI CTC
- measure
- Incidence and severity of renal dysfunction as determined by the NCI CTC
- measure
- Incidence and severity of mucositis as determined by the NCI CTC and WHO mucositis grading scale
- measure
- Incidence and severity of CNS toxicity and neurocognitive changes taken from patients' medical records and measured using the Mini-Mental State questionnaire and MRI data
Secondary outcomes (8)
- measure
- Hematological toxicity (i.e., number of courses of therapy associated with neutrophils < 0.5 x 10e9/L or platelets < 50 x 10e9/L as measured by routine blood counts)
- measure
- Incidence of infection (i.e., number of days with fever ≥ 38 C° measured by clinical examination and days of intravenous antibiotics taken from patients' medical records)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed primary CNS lymphoma (PCNSL) * Previously untreated disease * Diffuse large B-cell lymphoma histology * Must be clinically eligible to receive standard 3 g/m² methotrexate if outside trial * No clinically significant effusions or edema PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-3 * Neutrophils ≥ 1 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Bilirubin \< 1.5 times upper limit of normal * Glomerular filtration rate (initially measured by EDTA/isotope method) ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy Exclusion criteria: * HIV positivity * Dementia or neurological dysfunction not considered to be due to the PCNSL * Other serious or uncontrolled medical conditions * Prior malignancy, except adequately treated nonmelanoma skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: * No prior cytotoxic chemotherapy * No concurrent prophylactic antibiotics * No concurrent co-trimoxazole
References
Publications (0)
Data not yet available