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

Phase 2

• Conditions: Brain and Central Nervous System Tumors; Lymphoma; Metastatic Cancer
• Interventions: Drug: pemetrexed

• Registration Number: NCT00276783
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	pemetrexed	Pemetrexed 900 mg/m2 every 21 days until disease progression.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Collect safety data	After every cycle of therapy (cycle = 3 weeks) until disease progression or death.
Radiographic response	After 6 months of treatment
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	This was optional for patients.

Trial Locations

Locations (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States

Hematology-Oncology Associates of Illinois; 🇺🇸 Chicago, Illinois, United States