Treatment of Recurrent Primary or Secondary Central Nervous System (CNS) Lymphoma With ALIMTA (Pemetrexed)

Completed · Phase 1

Conditions studied: Central Nervous System Lymphoma

In brief

The purpose of this research study is to determine the safety of the study drug pemetrexed, and the highest dose of this drug that can be given to people safely. Another goal of this research study is to gain information about how the body handles pemetrexed and how pemetrexed may work to treat the participant's lymphoma in the nervous system. Pemetrexed (also known as Alimta) has been approved by the FDA for the treatment of some lung cancers and has been shown to be effective in laboratory studies. Information from these studies suggests that pemetrexed may help to treat patients with either primary or secondary central nervous system lymphoma.

Key facts

Study ID: NCT00916630
Run by: Massachusetts General Hospital
People needed: 18
Starts: 2009-01-01
Expected to finish: 2015-09-01
Last updated by the study team: 2015-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Disease state (5 categories of patients with these extremely rare disease are eligible: 1) Patients intolerant of Methotrexate-must have a diagnosis of B cell non-Hodgkin's lymphoma 2) Patients unable to receive methotrexate due to lack of drug availability-must have a diagnosis of B cell non-Hodgkin's lymphoma 3) Patients who fail to achieve a complete response to initial therapy for primary CNS lymphoma-must have a diagnosis of B cell non-Hodgkin's lymphoma 4) Recurrent Primary CNS lymphoma-If in the judgement of the treating physician therapy would be initiated without a repeat biopsy then the original biopsy with a diagnosis of B cell non-Hodgkin's lymphoma will suffice 5) Secondary CNS lymphoma-If in the judgement of the treating physician therapy would be initiated without a repeat biopsy then the original biopsy with a histologic diagnosis of B cell non-Hodgkin's lymphoma will suffice.
Histologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease OR cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease OR immunohistochemical diagnosis of monoclonality (CDF) with or without measurable intracranial disease OR molecular diagnostic diagnosis of monoclonality CSF) with or without measurable intracranial disease OR Ocular-patients may have a combination of histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma OR neurolymphomatosis-evidence of measurable disease as nerve seeking lymphoma on MRI imaging with histologic diagnosis at any site.
Karnofsky score of 60 or greater
Must be able to undergo MRI scanning
18 years of age or older
Life expectancy of at least 2 months
Laboratory values as outlined in protocol
Must be willing to practice an effective method of birth control during participation in the study whether male or female.

You may not qualify if…

Definitive histologic diagnosis of low grade lymphoma without substantive clinical suspicion of transformation to an aggressive lymphoma
Renal dysfunction defined as creatinine clearance < 45 ml/min or serum creatinine > 2mg/dL
Transaminases > 3 times above the upper limits of the institutional normal
Acute infection, granulocytopenia or medical condition precluding surgery as judged by the caring physician and review team
Pregnant or lactating females
Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment (with the exception of dexamethasone) or be a transplant recipient
Patients must not have received prior whole brain irradiation. They can have received prior focal irradiation
Prior participation in chemotherapy, cytotoxic therapy, immunotherapy or therapeutic protocols within 4 weeks fo enrollment. Patients unable to stop NSAIDS or Cox 2 inhibitors for two day before and after treatment as well as the day of treatment
No other active systemic malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ. Patients with a remote history (5 years or more) of malignancy are eligible for the protocol in the absence of active disease
Clinically relevant third space fluid collection refractory to drainage
Patient refusal to participate in the pK study

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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