Lymphoma
Conditions
Keywords
primary central nervous system non-Hodgkin lymphoma
Brief 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. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
Detailed description
OBJECTIVES: Primary * Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab. Secondary * Determine the progression-free and overall survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.
Interventions
BIOLOGICALrituximab
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed primary CNS lymphoma based on 1 of the following: * Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection * Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease * Histologically confirmed vitreal lymphoma with measurable intracranial tumor * CD20 positive by brain biopsy * Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI * Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment * No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast * No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry * No ocular lymphoma by slit lamp examination PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * Transaminases less than 4 times upper limit of normal Renal * Creatinine less than 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * HIV negative * Mini mental status examination score at least 15 * No concurrent serious infection * No other medical illness that would preclude study treatment * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy * More than 90 days since prior biologic therapy * No prior rituximab * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery * Not specified Other * Recovered from prior therapy * More than 90 days since prior investigational drugs * More than 90 days since prior use of a therapeutic device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Response | 1 month, 2 months and then q3months | it at any time point patient progresses no more scans are required, patient is off study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | pt had MRI q3months | pt had MRI every 3 months |
| Overall Survival | 47 months | survival was evaluated q 2months |
| Toxicity | 8 weeks - 2 cycles | patients only received drug for 8 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Rituximab Monotherapy |
|---|---|
| Age Continuous age, years | 64 years |
| Karnofsky Performance Status Scale | 85 Score |
| Mini-Mental State Examination (MMSE) | 29 Score |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Radiographic Response
it at any time point patient progresses no more scans are required, patient is off study
Time frame: 1 month, 2 months and then q3months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab Monotherapy | Radiographic Response | 4 participants |
Secondary
Overall Survival
survival was evaluated q 2months
Time frame: 47 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab Monotherapy | Overall Survival | 20.9 months |
Secondary
Progression-free Survival
pt had MRI every 3 months
Time frame: pt had MRI q3months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab Monotherapy | Progression-free Survival | 57 days |
Secondary
Toxicity
patients only received drug for 8 weeks
Time frame: 8 weeks - 2 cycles
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab Monotherapy | Toxicity | 4 related episodes |