Clinical trial · Interventional
Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma
NCT00045539CI-TRIAL-00011018completedPhase 2ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete radiographic response
Secondary outcomes (4)
- measure
- Duration of progression-free survival and overall survival
- measure
- Toxicity
- measure
- Association of tumor BCL-6 expression with response
- measure
- Relationship among initial response to steroids, response to chemotherapy, and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary CNS lymphoma
* Confirmed by 1 of the following:
* Brain biopsy or resection
* CSF cytology
* Positive cytology or immunohistochemical diagnosis of monoclonality and measurable intracranial tumor
* Vitreal biopsy
* Measurable and contrast-enhancing disease on the postoperative, pretreatment MRI or CT scan
* No radiographic evidence of ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL
* SGOT no greater than 4 times upper limit of normal
Renal
* Creatinine no greater than 2 mg/dL
* Creatinine clearance at least 50 mL/min
Other
* Mini mental score of at least 15
* HIV negative
* Able to achieve hydration
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
* No allergy to methotrexate
* No serious infection
* No medical illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy or biologic therapy for this disease
Chemotherapy
* No prior chemotherapy for this disease
* No other concurrent chemotherapeutic agents
Endocrine therapy
* No prior hormonal therapy for this disease
* Prior glucocorticoid therapy allowed
Radiotherapy
* No prior radiotherapy for this disease
* No prior cranial irradiation
Surgery
* See Disease Characteristics
Other
* At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs, probenecid, folic acid, or sulfonamide medications
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.