Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

UNKNOWN

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

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief 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 i...

Detailed Description

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 patie...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2022

    Estimated Enrollment :

    31 Patients enrolled

    Trial Details

    Trial ID

    NCT00276783

    Start Date

    November 1 2005

    End Date

    December 1 2022

    Last Update

    March 5 2020

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Hematology-Oncology Associates of Illinois

    Chicago, Illinois, United States, 60611-2998

    2

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013