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

NCT00276783 | Unknown Phase 2 DMC

• 4 other identifiers: NU 05C2P30CA060553NU-05C2STU00007255
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

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

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

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

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

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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Drug: pemetrexed

Interventions

pemetrexed DRUG

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

Also known as: pemetrexed disodium, Alimta

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma; Neoplasm Metastasis; Brain Neoplasms; Glioblastoma; Gliosarcoma; Glioma; Astrocytoma; Oligodendroglioma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Jeffrey J. Raizer, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

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 1, 2005
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

US (2)