NCT00072449 · REGISTRY CONDITION SEARCH

Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2013-08-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Radiographic Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Toxicity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
intervention Names
Biological: rituximab
label
Rituximab monotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
Rituximab monotherapy
name
rituximab
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
it at any time point patient progresses no more scans are required, patient is off study
measure
Radiographic Response
time Frame
1 month, 2 months and then q3months

secondary Outcomes

description
pt had MRI every 3 months
measure
Progression-free Survival
time Frame
pt had MRI q3months
description
survival was evaluated q 2months
measure
Overall Survival
time Frame
47 months
description
patients only received drug for 8 weeks
measure
Toxicity
time Frame
8 weeks - 2 cycles

Full study description

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.

Source references

references

citation
Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.
pmid
21383331
type
BACKGROUND

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-95cffae651705a4dbb8e
requested nct id
NCT00072449
primary nct id
NCT00072449
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Primary+Central+Nervous+System+Lymphoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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payload
clinical indication matching status
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end exclusive
true
id
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link basis
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nct id
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occurrences
context exact
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exact text
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start
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offset unit
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query cond
Primary Central Nervous System Lymphoma
query disease state id
ds-primary-central-nervous-system-lymphoma
source file
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source file sha256
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source json pointer
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source kind
ctgov_condition_query
source record id
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source string basis
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source string sha256
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source url
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Preserved source evidence · Not medical advice