Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Lymphoma Metastatic Cancer

Keywords

primary central nervous system lymphomatumors metastatic to brainrecurrent adult brain tumoradult giant cell glioblastomaadult gliosarcomaadult mixed gliomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult glioblastoma

Outcome Measures

Primary Outcomes (1)

Progression free survival at 6 months and time to disease progression
After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression

Secondary Outcomes (4)

Radiographic response
After 6 months of treatment
Collect safety data
After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
Overall survival

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: pemetrexed

Interventions

pemetrexedDrug

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

Also known as: pemetrexed disodium, Alimta

Treatment Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Northwestern University
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (2)

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaNeoplasm MetastasisBrain NeoplasmsGlioblastomaGliosarcomaGliomaAstrocytomaOligodendroglioma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic Type

Study Officials

Jeffrey J. Raizer, MD
Robert H. Lurie Cancer Center
STUDY CHAIR

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations