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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00596154
Other study ID # 04-129
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2004
Est. completion date February 2, 2023

Study information

Verified date February 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date February 2, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 72 Years
Eligibility 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.

Study Design


Intervention

Other:
Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
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.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Evaluated for Toxicity 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. 1 year
Secondary Overall Response Rates To evaluate response rates with the combination of rituximab and MPV as induction chemotherapy. after 10 weeks (5 cycles)
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