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

Primary Purpose

Brain and Central Nervous System Tumors, Lymphoma, Metastatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hematology-Oncology Associates of Illinois
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival at 6 months and time to disease progression

Secondary Outcome Measures

Radiographic response
Collect safety data
Overall survival
Compare blood and tissue methylation patterns and correlate with response.
This was optional for patients.

Full Information

First Posted
January 12, 2006
Last Updated
March 4, 2020
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276783
Brief Title
Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases
Official Title
A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Lymphoma, Metastatic Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Pemetrexed 900 mg/m2 every 21 days until disease progression.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
pemetrexed disodium, Alimta
Intervention Description
Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Radiographic response
Time Frame
After 6 months of treatment
Title
Collect safety data
Time Frame
After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
Title
Overall survival
Time Frame
After every cycle of treatment (1 cycle = 3 weeks) until death
Title
Compare blood and tissue methylation patterns and correlate with response.
Description
This was optional for patients.
Time Frame
Blood and tissue from baseline, then additional blood every 6 weeks while on treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J. Raizer, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology-Oncology Associates of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2998
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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