Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment … (NCT00074165) | Clinical Trial Compass
TerminatedPhase 2
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
Stopped: Lack of accrual
United States17 participantsStarted 2003-01
Plain-language summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use 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 tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
Who can participate
Age range
18 Months – 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.
INCLUSION CRITERIA:
* Signed informed consent form in accordance with institutional guidelines
* Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
* CD20 positive disease
* Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy
* Aged 18 months to 75 years
* Performance status ECOG 0-3 OR Karnofsky 30-100%
* Hematocrit at least 25% (transfusion or epoetin alfa allowed)
* Absolute granulocyte count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3 OR at least lower limit of normal
* Bilirubin no greater than 2.0 times upper limit of normal
* Creatinine less than 1.8 mg/dL
* Calculated Creatinine clearance (CrCl) at least 50 mL/min
* Adequate cardiac function to tolerate general anesthesia
* Adequate pulmonary function to tolerate general anesthesia
* Available for follow-up for 1 year post therapy
* Fertile patients must use effective contraception for a minimum of 2 months before and during study participation
EXCLUSION CRITERIA:
* Radiographic signs of intra-cranial herniation and/or spinal block
* HIV positive
* Systemic lymphoma
* Positive serum HCG, pregnant or lactating
* Allergy to study agents
* Hepatitis B or hepatitis C positive
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
Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.