Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma
This trial is active, not recruiting.
|Conditions||cns lymphoma, cns brain cancer, non-hodgkin's lymphoma|
|Treatment||rituximab, methotrexate, vincristine, procarbazine, pbpcs collection, busulfan, thiotepa, and cyclophosphamide|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||December 2004|
|End date||December 2016|
|Trial size||33 participants|
|Trial identifier||NCT00596154, 04-129|
The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Basking Ridge, NJ||Memorial Sloan-Kettering at Basking Ridge||no longer recruiting|
|Commack, NY||Memorial Sloan-Kettering Cancer Center at Commack||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
to evaluate the safety and efficacy of the use of R-MPV followed by high-dose chemotherapy using thiotepa, cyclophosphamide and busulfan with stem cell rescue in patients with newly diagnosed PCSNL.
time frame: 1-year event-free survival and acute treatment-related toxicity.
to evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.
time frame: after 5 cycles
Male or female participants from 18 years up to 72 years old.
Inclusion Criteria: - All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers. A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy. - Patients must be HIV-1 negative. - Patient must have left ventricular ejection fraction ≥ 50%. - Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration. - Patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73M2). - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. - Patients must be between 18 and 72 years-old. - Patients must sign an informed consent. Exclusion Criteria: - Prior cranial irradiation - Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ. - Pre-existing immunodeficiency such as renal transplant recipient. - Prior treatment with chemotherapy for CNS lymphoma.
|Official title||Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)|
|Principal investigator||Antonio Omuro, MD|
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