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

NCT ID: NCT00276783

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2022-12-31

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.

Conditions

Brain and Central Nervous System Tumors; Lymphoma; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

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

Interventions

pemetrexed

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

Intervention Type: DRUG

Other Intervention Names

pemetrexed disodium; Alimta

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey J. Raizer, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Hematology-Oncology Associates of Illinois

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU-05C2

Identifier Type: -

Identifier Source: secondary_id

STU00007255

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05C2

Identifier Type: -

Identifier Source: org_study_id