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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00276783
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeffrey J. Raizer, MD
Principal Investigator Affiliation Robert H. Lurie Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Lymphoma, Metastatic Cancer
Additional Details

OBJECTIVES: Primary.

  • - Determine the 6-month progression-free survival rate in patients with recurrent malignant gliomas treated with pemetrexed disodium.
  • - Determine the time to progression in patients with recurrent malignant gliomas, primary CNS lymphoma (PCNSL), or brain metastases treated with pemetrexed disodium.
Secondary.
  • - Determine the radiographic response in patients with recurrent malignant gliomas, PCNSL, or brain metastases treated with pemetrexed disodium.
  • - Determine the time to response in patients treated with this drug.
  • - Determine the duration of response in patients treated with this drug.
  • - Determine the overall survival of patients treated with this drug.
  • - Collect safety data on patients with intracranial tumors treated with this drug.
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Arms & Interventions

Arms

Experimental: Treatment Arm

Pemetrexed 900 mg/m2 every 21 days until disease progression.

Interventions

Drug: - pemetrexed

Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Address

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998

Chicago, Illinois

Status

Address

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013