A Phase I Study of the Treatment of Recurrent Primary or Secondary CNS Lymphoma With ALIMTA (Pemetrexed), a Novel Anti-Folate
- Since we are looking for the highest dose of pemetrexed that can be given to people
safely, not everyone who participates in this study will be receiving the same amount
of the study drug. The dose participants will receive will depend upon the number of
people that have been enrolled on the study before them and how well they have
tolerated their doses of the study drug.
- Pemetrexed is given into a vein (by IV) over a 10 to 20 minute period once every 14
days. This 14 day period is called a cycle of study treatment.
- Study treatment will be divided into three phases. Induction: Participants will be
given a maximum of 8 cycles. If the participant does not achieve a complete response
after eight induction cycles, they will be taken off study. A complete response means
there is no evidence of disease on MRI or CT scan. Consolidation: If the participant
has achieved complete response, they will have two additional cycles. Maintenance:
Following the completion of the consolidation cycles, participants will receive the
study drug only once per month. They can continue to receive maintenance cycles for up
to a year from the start of the first induction cycle.
- Folic acid and vitamin B12 are two vitamins that have been shown to help lessen the
severity of some side effects of pemetrexed. Participants will begin taking oral folic
acid tablets at least 5 days before their first dose of pemetrexed and daily until 3
weeks after their last dose. Vitamin B12 is given through injections into your muscle.
Participants will receive their first vitamin B12 injection 1-2 weeks before their
first dose of pemetrexed. They will receive injections every 9 weeks.
- Corticosteroids such as dexamethasone have been shown to help prevent severe skin
rashes associated with pemetrexed. Participants will receive dexamethasone twice daily
starting the day before each pemetrexed infusion continuing until the day after each
- On day 1 of each cycle the following will be performed: a physical examination, blood
work, vital signs, assessment of who well the participant is functioning, and
mini-mental examination. On day 8 of each cycle blood work will be performed.
- Research blood work will be obtained (PKs) over the first four days of cycles 1 and 2
(or study participation days 1-4 and 15-18).
- Participants will come to the clinic once a month during the maintenance cycles for a
physical examination, blood work, assessment of how well the participant is
functioning, vital signs and mini-mental examination.
- Tumor assessments by MRI will be done after every 2 cycles during the induction and
consolidation cycles. During the maintenance cycles the MRIs will be repeated every 2
cycles (once every 2 months).
- Collection of cerebral spinal fluid (CSF) for research tests will also likely be
performed, if safe for you, to learn more about how well pemetrexed can cross the
blood-brain barrier. This will be performed by one of two methods 6 and 24 hours after
the pemetrexed is infused on days 1 and 2 of the first two cycles.
- After Alimta is given you will also receive, a white blood cell recruiting material,
Neupogen to avoid suppressing your bone marrow.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and to determine the maximum tolerated dose of pemetrexed given intravenously for the treatment of recurrent lymphoma invading the CNS.
Fred Hochberg, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|