Clinical trial · Interventional
Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
NCT00276783CI-TRIAL-00043832unknownPhase 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: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.
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 | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Pemetrexed 900 mg/m2 every 21 days until disease progression.
- interventionNames
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Progression free survival at 6 months and time to disease progression
- timeFrame
- After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression
Secondary outcomes (4)
- measure
- Radiographic response
- timeFrame
- After 6 months of treatment
- measure
- Collect safety data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Malignant glioma, including the following subtypes: glioblastoma or gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, or malignant glioma not otherwise specified, meeting the following criteria:
* Not required to have measurable or evaluable disease
* Must have failed prior radiation therapy \> 4 weeks ago
* Must have failed at least 1 prior chemotherapy regimen
* Confirmation of tumor progression by MR spectroscopy, PET scan, or biopsy/resection if prior radiosurgery was performed
* Primary CNS lymphoma, meeting the following criteria:
* Measurable disease as defined by bidimensionally measurable lesions with clearly defined margins by CT scan or MRI
* Must have failed at least one prior chemotherapy regimen
* Must have failed at least one agent or regimen
* Brain metastases from a solid tumor, meeting the following criteria:
* Measurable disease as defined by bidimensionally measurable lesions with clearly defined margins by CT scan or MRI
* Biopsy is not required if radiographic imaging is consistent with brain metastases
* Must have failed prior whole-brain radiotherapy
* Patients with leptomeningeal metastases with or without brain metastases are eligible for therapy (may be diagnosed by MRI or cytology)
* Confirmation of tumor progression by MR spectroscopy, PET scan, or biopsy/resection if prior radiosurgery was performed
* Effusions or fluid collections must be drained prior to study entry
PATIENT CHARACTERISTICS:
* Karnofsky performance score ≥ 60
* WBC \> 3,000/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 10 mg/dL (transfusion allowed)
* SGOT/SGPT \< 3.0 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Creatinine \< 1.5 mg/dL
* Creatinine clearance \> 45 mL/min
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study and for 3 months after completing study treatment
* Women who are pregnant or breast-feeding are not eligible for study treatment
* Negative pregnancy test
* Able to take steroids, vitamin B12, or folate
* No significant medical illnesses or infection that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
* Only one active tumor type allowed, except nonmelanoma skin cancer or carcinoma in situ of the cervix
* A history of other malignancies are acceptable if in complete remission and off all therapy for that disease for a minimum of 3 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior whole-brain or other radiotherapy
* Recovered from any side effects (6 weeks for a nitrosourea; 4 weeks for temozolomide, procarbazine, etoposide or experimental agent; 3 weeks for isotretinoin or tamoxifen) (for patients with gliomas)
* No more than 2 prior chemotherapeutic agents or regimens (includes biologic agents) (for patients with gliomas)
* Recovered from prior biopsy or re-resection of the tumor (10-14 days for resection or 3-5 days for a biopsy) (for patients with gliomas)
* May not be on any other chemotherapy except for hormonal therapy or trastuzumab (Herceptin®) (for patients with brain metastases)
* No limitations on prior CNS-directed therapies (for patients with brain metastases)
* Able to discontinue nonsteroidal anti-inflammatory drugs (NSAIDs)
* Patients taking NSAIDs or aspirin are required to interrupt therapy for at least 2 days before the study treatment and 2 days after the infusionReferences
Publications (0)
Data not yet available
No reference posted for this study.