Lymphoma
Conditions
Keywords
Lymphoma, Central Nervous System
Brief summary
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.
Detailed description
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor. The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.
Interventions
DRUGCytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Immunochemotherapy
Sponsors
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria: * A positive cerebrospinal fluid (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 * A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s) * Patients must be HIV-1 negative * Patients must have a normal or negative pre-treatment systemic evaluation including: * A bone marrow aspirate and biopsy * CT scans of the chest, abdomen and pelvis * Patients must have adequate bone marrow function (defined as peripheral leucocyte count \> 4000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \< 2.0 mg and SGOT \< 2 times upper limit of normal), and adequate renal function (serum creatinine \< 1.5 mg/dl or creatinine clearance \> 50 cc/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
Exclusion criteria
The following would exclude a patient from the study: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants Who Experienced Acute Treatment Related Adverse Events | 2 years | The toxicity of this combined regimen will be measured using the NCI CTC version 2.0. |
| Progression Free Survival | 2 Years | Overall Progression Free Survival at 2 years |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 Recruitment Location is the medical clinic
Participants by arm
| Arm | Count |
|---|---|
| Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Never Treated | 3 |
| Overall Study | Toxicity | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 60 Years |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 52 |
| other Total, other adverse events | 43 / 52 |
| serious Total, serious adverse events | 22 / 52 |
Outcome results
Primary
Progression Free Survival
Overall Progression Free Survival at 2 years
Time frame: 2 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma | Progression Free Survival | 57 percentage of participants |
Primary
Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma | Total Number of Participants Who Experienced Acute Treatment Related Adverse Events | 52 Participants |