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Brain and Central Nervous System TumorsPhase 2NCT00276783

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

A Phase 2 study testing pemetrexed in people with Brain and Central Nervous System Tumors and Lymphoma, run by Northwestern University at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
Nov 2005to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Hematology-Oncology Associates of Illinois

    Chicago, Illinois, 60611-2998

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
pemetrexed
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
Medical subject headings
Central Nervous System Neoplasms, Lymphoma, Neoplasm Metastasis, Brain Neoplasms, Glioblastoma, Gliosarcoma, Glioma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pemetrexedDrug

    Also called pemetrexed disodium, Alimta

    Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.

Study groups in NCT00276783
Study groupRoleWhat they receive
Treatment ArmExperimentalPemetrexed 900 mg/m2 every 21 days until disease progression.
Receives: Drug: pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival at 6 months and time to disease progression

    Measured: After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression

Secondary outcomes (4)
  1. Radiographic response

    Measured: After 6 months of treatment

  2. Collect safety data

    Measured: After every cycle of therapy (cycle = 3 weeks) until disease progression or death.

  3. Overall survival

    Measured: After every cycle of treatment (1 cycle = 3 weeks) until death

  4. Compare blood and tissue methylation patterns and correlate with response.

    This was optional for patients.

    Measured: Blood and tissue from baseline, then additional blood every 6 weeks while on treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276783
Sponsor's protocol ID
NU 05C2
Other IDs
P30CA060553, NU-05C2, STU00007255
Status last verified
Mar 2020
First submitted
12 Jan 2006
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed in people with Brain and Central Nervous System Tumors and Lymphoma, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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