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

March 4, 2020 updated by: Northwestern University

A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60611-2998
        • Hematology-Oncology Associates of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Alimta
  • pemetrexed disodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic response
Time Frame: After 6 months of treatment
After 6 months of treatment
Collect safety data
Time Frame: After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
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
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.
Blood and tissue from baseline, then additional blood every 6 weeks while on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jeffrey J. Raizer, MD, Robert H. Lurie Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (ESTIMATE)

January 13, 2006

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 05C2
  • P30CA060553 (U.S. NIH Grant/Contract)
  • NU-05C2
  • STU00007255 (OTHER: Northwestern University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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