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Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
This study is ongoing, but not recruiting participants.

First Received on January 12, 2006.   Last Updated on May 19, 2011   History of Changes
Sponsor: Northwestern University
Collaborator: National Cancer Institute (NCI)
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00276783
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Lymphoma
Metastatic Cancer
Drug: pemetrexed
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Progression free survival at 6 months and time to disease progression [ Time Frame: After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic response [ Time Frame: After 6 months of treatment ] [ Designated as safety issue: No ]
  • Collect safety data [ Time Frame: After every cycle of therapy (cycle = 3 weeks) until disease progression or death. ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: After every cycle of treatment (1 cycle = 3 weeks) until death ] [ Designated as safety issue: No ]
  • Compare blood and tissue methylation patterns and correlate with response. [ Time Frame: Blood and tissue from baseline, then additional blood every 6 weeks while on treatment ] [ Designated as safety issue: No ]
    This was optional for patients.


Enrollment: 31
Study Start Date: November 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Pemetrexed 900 mg/m2 every 21 days until disease progression.
Drug: pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Other Names:
  • pemetrexed disodium
  • Alimta

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276783

Locations
United States, Illinois
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey J. Raizer, Robert H. Lurie Comprehensive Cancer Center at Northwestern University
ClinicalTrials.gov Identifier: NCT00276783     History of Changes
Other Study ID Numbers: NU 05C2, P30CA060553, NU-05C2
Study First Received: January 12, 2006
Last Updated: May 19, 2011
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
primary central nervous system lymphoma
tumors metastatic to brain
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
adult mixed glioma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma

Additional relevant MeSH terms:
Glioma
Lymphoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012