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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276783
Recruitment Status : Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE November 2005
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00276783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
  • Radiographic response [ Time Frame: After 6 months of treatment ]
  • Collect safety data [ Time Frame: After every cycle of therapy (cycle = 3 weeks) until disease progression or death. ]
  • Overall survival [ Time Frame: After every cycle of treatment (1 cycle = 3 weeks) until death ]
  • 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 ]
    This was optional for patients.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
Official Title  ICMJE A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
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 in treating patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Lymphoma
  • Metastatic Cancer
Intervention  ICMJE Drug: pemetrexed
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Other Names:
  • pemetrexed disodium
  • Alimta
Study Arms  ICMJE Experimental: Treatment Arm
Pemetrexed 900 mg/m2 every 21 days until disease progression.
Intervention: Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 19, 2011)
31
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276783
Other Study ID Numbers  ICMJE NU 05C2
P30CA060553 ( U.S. NIH Grant/Contract )
NU-05C2
STU00007255 ( Other Identifier: Northwestern University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
PRS Account Northwestern University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP