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.
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
- Conditions the study is for
- Brain and Central Nervous System Tumors, Lymphoma, Metastatic Cancer
- 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
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 group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Pemetrexed 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.
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)
Radiographic response
Measured: After 6 months of treatment
Collect safety data
Measured: After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
Overall survival
Measured: After every cycle of treatment (1 cycle = 3 weeks) until death
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.
- First posted13 Jan 2006 (estimated)
- Study startNov 2005
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey J. Raizer, MD, Study chair, Robert H. Lurie Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
- ClinicalTrials.gov ID
- NCT00276783
- Acronym / sponsor ID
- NU 05C2
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: pemetrexedPemetrexed 900 mg/m2 every 21 days until disease progression. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: pemetrexed disodium, AlimtaAdministered intravenously at a dose of 900 mg/m2 every 21 days until disease progression. | Drug | Treatment Arm |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Raizer, MD study chair
Robert H. Lurie Cancer Center
2 sites in 1 country: see every site and its status.
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.