Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pemetrexed

Criteria

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 infusion