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
Phase phase 2
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Rituximab, methotrexate (MTX), procarbazine and vincristine (R-MPV). The peripheral blood stem cell (PBSC) harvest procedure will be performed at the discretion of the hematology attending (usually after the 1st or 2nd cycle of R-MPV)and high dose chemotherapy Busulfan, Thiotepa, and Cyclophosphamide.
rituximab, methotrexate, vincristine, procarbazine, pbpcs collection, busulfan, thiotepa, and cyclophosphamide During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be
The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1. On day 2 you will be admitted to the hospital and will receive 3 other drugs: Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2. Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.

Primary Outcomes

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.

Secondary Outcomes

to evaluate response rates with the combination of rituximab and MPV as induction chemotherapy.
time frame: after 5 cycles

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.