Clinical trial · Interventional
Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma
Pilot Study to Determine Therapeutic Response of Pemetrexed (Alimta) in Recurrent or Progressive Primary Central Nervous System Lymphoma (PCNSL) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria
NCT00712062CI-TRIAL-00005508withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine if pemetrexed is effective in the treatment of primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or has returned after completing treatment.
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 |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed
- description
- 500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
- interventionNames
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Determine the therapeutic response of intravenous pemetrexed in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria.
- timeFrame
- 2.5 Years
Secondary outcomes (2)
- measure
- Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.
- timeFrame
- 2.5 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of Primary Central Nervous System Lymphoma * Male or female \> 18 years of age or older * Negative pregnancy test (if of childbearing potential) * Any number of previous recurrences will be allowed * Karnofsky Performance Status \> 60 * Hematocrit \> 30,000 * Platelet \> 100,000 * Absolute Neutrophil Count \> 1,500 * Bilirubin \< 1.5 x upper limits of normal * Transaminases (ALT and AST) \< 1.5 x upper limits of normal * Creatinine \< 1.5 x upper limits of normal * Creatinine Clearance \> 45 mL/min * Adequate medical health to participate in this study * Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal) * Ability to read and understand the patient informed consent form * Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms Exclusion Criteria: * Karnofsky Performance Status \< 60 * Hematocrit \< 30,000 * Platelet \< 100,000 * Absolute Neutrophil Count \< 1,500 * Bilirubin \>1.5 x upper limits of normal * Transaminases (ALT \& AST) \> 1.5 x upper limits of normal * Creatinine \> 1.5 x upper limits of normal * Creatinine Clearance \< 45 mL/min * Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
References
Publications (0)
Data not yet available
No reference posted for this study.