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Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Pemetrexed

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring PCNSL, Pemetrexed, Alimta, Recurrent, Progressive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological confirmation of Primary Central Nervous System Lymphoma
Male or female > 18 years of age or older
Negative pregnancy test (if of childbearing potential)
Any number of previous recurrences will be allowed
Karnofsky Performance Status > 60
Hematocrit > 30,000
Platelet > 100,000
Absolute Neutrophil Count > 1,500
Bilirubin < 1.5 x upper limits of normal
Transaminases (ALT and AST) < 1.5 x upper limits of normal
Creatinine < 1.5 x upper limits of normal
Creatinine Clearance > 45 mL/min
Adequate medical health to participate in this study
Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
Ability to read and understand the patient informed consent form
Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms

Exclusion Criteria:

Karnofsky Performance Status < 60
Hematocrit < 30,000
Platelet < 100,000
Absolute Neutrophil Count < 1,500
Bilirubin >1.5 x upper limits of normal
Transaminases (ALT & AST) > 1.5 x upper limits of normal
Creatinine > 1.5 x upper limits of normal
Creatinine Clearance < 45 mL/min
Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed

Arm Description

500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Determine the therapeutic response of intravenous pemetrexed in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria.

Secondary Outcome Measures

Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.

Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.

Full Information

NCT ID

NCT00712062

First Posted

July 3, 2008

Last Updated

September 16, 2011

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT00712062

Brief Title

Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

Official Title

Pilot Study to Determine Therapeutic Response of Pemetrexed (Alimta) in Recurrent or Progressive Primary Central Nervous System Lymphoma (PCNSL) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of accrual

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if pemetrexed is effective in the treatment of primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or has returned after completing treatment.

Detailed Description

Despite the aggressive upfront use of methotrexate-based chemotherapy, primary central nervous system lymphoma (PCNSL) almost uniformly results in recurrence or progression and death. Palliative chemotherapy offers an improvement in time-to-progression, symptom control, quality of life, and potentially, survival. However, no established chemotherapy regimen for recurrence exists and new treatments are needed. Pemetrexed is a rationale strategy for therapeutic palliation of recurrent or progressive PCNSL, given its mechanism of action, convenient administration, single agent efficacy, its well established management algorithms, and its evidence of safety and efficacy in systemic malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

Keywords

PCNSL, Pemetrexed, Alimta, Recurrent, Progressive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed

Arm Type

Experimental

Arm Description

500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Time Frame

2.5 Years

Secondary Outcome Measure Information:

Title

Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.

Time Frame

2.5 Years

Title

Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.

Time Frame

2.5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological confirmation of Primary Central Nervous System Lymphoma Male or female > 18 years of age or older Negative pregnancy test (if of childbearing potential) Any number of previous recurrences will be allowed Karnofsky Performance Status > 60 Hematocrit > 30,000 Platelet > 100,000 Absolute Neutrophil Count > 1,500 Bilirubin < 1.5 x upper limits of normal Transaminases (ALT and AST) < 1.5 x upper limits of normal Creatinine < 1.5 x upper limits of normal Creatinine Clearance > 45 mL/min Adequate medical health to participate in this study Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal) Ability to read and understand the patient informed consent form Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms Exclusion Criteria: Karnofsky Performance Status < 60 Hematocrit < 30,000 Platelet < 100,000 Absolute Neutrophil Count < 1,500 Bilirubin >1.5 x upper limits of normal Transaminases (ALT & AST) > 1.5 x upper limits of normal Creatinine > 1.5 x upper limits of normal Creatinine Clearance < 45 mL/min Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin M Dunbar, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study of Pemetrexed to Treat Recurrent or Progressive Primary Central Nervous System Lymphoma

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