Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Di… (NCT00074178) | Clinical Trial Compass
CompletedPhase 2
Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
United States22 participantsStarted 2000-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma.
Who can participate
Age range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma by brain biopsy or cerebrospinal fluid or vitrectomy analysis
* No more than 90 days since diagnosis
* No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 16 to 75
Performance status
* ECOG 0-3 OR
* Karnofsky 40-100%
Life expectancy
* Not specified
Hematopoietic
* Hematocrit at least 25% (transfusion allowed)
* WBC at least 2,500/mm\^3
* Absolute granulocyte count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3 OR at least lower limit of normal (transfusion independent)
Hepatic
* Bilirubin no greater than 2.0 times upper limit of normal
Renal
* Creatinine clearance at least 30 mL/min
Cardiovascular
* Adequate cardiac function to tolerate general anesthesia
Pulmonary
* Adequate pulmonary function to tolerate general anesthesia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 2 months before and during study participation
* No other uncontrolled clinically significant confounding medical condition within the past 30 days
* No known allergy to study agents
* HIV negative
PRIOR CONCURR…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival as measured by clinical and radiographic response at 5 years after study treatment